Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
Response to Amendment
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/2026 has been entered.
Newly amended Claims 31, 37, and 40-53 are pending in the application.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Regarding the rejection over Weber, applicant argues new limitations which are addressed in the new rejection issued below, necessitated by amendment.
Applicant argues “Weber does not specifically disclose a treatment for patients already having Type II diabetes”. However, Weber describes concomitant conditions associated with obesity and does not preclude diabetes. Applicant’s scope is not excluded by Weber’s disclosure. Weber also teaches the treatment of symptoms associated with Type II diabetes: “Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.” (8/15/2025 Office Action: Page 7). Applicant’s argument is fully considered but not persuasive. It would be obvious to treat the concomitant condition with the Weber method because of the close association of both conditions and Weber’s explicit teaching of the treatment of symptoms associated therewith.
Further, applicant does not claim treating any particular condition, only that the patient is obese or overweight with Type 2. As long as it would be obvious to treat any of the above conditions, or any condition at all, which are not identified as particular conditions to be treated, the claim is rendered obvious. If applicant would prefer specific treatment of a particular disorder, it is suggested that applicant amend the language to read “A method of treating obesity in a patient…” or “…Type 2 diabetes in a patient”, for example.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 31, 37, 40-53 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant adds the limitation to Claims 31 and 49 “wherein insulin resistance is reduced by about 1% or about 100%”. The specification does not disclose such a feature. Applicant describes reducing symptoms of insulin resistance in Para 76. Insulin resistance and symptoms thereof encompass different scopes and therefore the new limitation constitutes a new matter situation. Claims 37, 40-48, and 50-53 are rejected by virtue of dependency.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 31, 37, 40-53 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 31 and 49 recite “wherein insulin resistance is reduced by about 1% or about 100%”. It is unclear whether the reduction is of insulin resistance itself or symptoms thereof. Also, it is unclear how insulin resistance might be quantified for therapeutic use in the methods claimed by applicant. Claims 37, 40-48, and 50-53 are rejected by virtue of dependency.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 31, 37, and 40-53 are rejected under 35 U.S.C. 103 as being unpatentable over Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) in view of Hirsch (JAMA. 2003;289(17):2254–2264).
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Weber does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
PROVISIONAL:
1. Claims 31, 37, and 40-53 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 35, 38-46, 48, 51, 53, 56, and 58 of copending Application No. 17319882 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion and naltrexone.
Nalpropion does not teach methods of administering particular amounts of either API or treating Type II diabetes. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both applications teach a method of administering combinations of bupropion and naltrexone to treat related conditions the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
This is a provisional nonstatutory double patenting rejection.
2. Claims 31, 37, and 40-53 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 21-40 of copending Application No. 17346902 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion (360mg) and naltrexone (32mg) in sustained release formulations multiple times per day.
Nalpropion does not teach concomitant Type II diabetes. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both applications teach a method of administering combinations of bupropion and naltrexone to treat related conditions the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
This is a provisional nonstatutory double patenting rejection.
3. Claims 31, 37, and 40-53 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 36-38 of copending Application No. 18143254 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion and naltrexone in controlled release formulations.
Nalpropion does not teach the treatment of concomitant Type II diabetes or narrow amounts of APIs. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both applications teach a method of administering combinations of bupropion and naltrexone to treat related conditions the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
This is a provisional nonstatutory double patenting rejection.
4. Claims 31, 37, and 40-53 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claim 1 of copending Application No. 18731965 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating a subject at “increased risk of major adverse cardiovascular event (MACE)” comprising administering combinations of bupropion and naltrexone.
Nalpropion teaches obesity and Type II diabetes qualify a patient as having an increased risk of MACE (Para 6-7). However, no specific regimen is taught. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient. Further, the treatment of obesity or related comorbidities would reduce cardiovascular stress and MACE resulting therefrom.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both applications teach a method of administering combinations of bupropion and naltrexone to treat related conditions the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
This is a provisional nonstatutory double patenting rejection.
5. Claims 31, 37, and 40-53 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-29 of copending Application No. 19211696 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion and naltrexone in sustained release formulations multiple times per day.
Regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1).
Nalpropion does not teach particular concentrations of either API. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both applications teach a method of administering combinations of bupropion and naltrexone to treat related conditions the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
This is a provisional nonstatutory double patenting rejection.
NONPROVISIONAL:
1. Claims 31, 37, 40-47, and 49-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-49 of U.S. Patent No. 7462626 (hereinafter referred to as Nalpropion) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating blood-glucose disorders, including obesity, comprising administering combinations of bupropion and naltrexone with zonisamide in sustained release single oral dosage forms one or multiple times per day to a patient with non-insulin dependent also known as Type II diabetes.
Nalpropion teaches a broader range (5-50mg) of naltrexone than the examined claims (25-38mg) and a broader range (30-500mg) of bupropion than the examined claims (300-400mg). However, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I. Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A).
Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat a blood-glucose condition, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
2. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 8722085 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity, comprising administering combinations of bupropion (360mg) and naltrexone (32mg) in sustained release formulations.
Regarding particular amounts of API taught in Nalpropion, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I. Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A).
Nalpropion fails to teach auxiliary method steps like the supplementation of dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
3. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-21, 23, 25, 27, and 29-31 of U.S. Patent No. 8815889 (hereinafter referred to as Nalpropion) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity and Type II diabetes comprising administering combinations of the same amounts of bupropion and naltrexone in sustained release formulations in a single oral dosage or separately as pills, capsules, or tablets to an obese patient with Type II diabetes. Additional steps include monitoring blood-glucose, changing dosage amounts, and providing dietary instructions.
Nalpropion fails to teach the administration of zonisamide. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
4. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-15 of U.S. Patent No. 8916195 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity, comprising administering combinations of bupropion (360mg) and naltrexone (32mg) in sustained release formulations.
Regarding particular amounts of API taught in Nalpropion, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 I. Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A).
Nalpropion fails to teach auxiliary method steps like the supplementation of dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
5. Claims 31, 35, 37, and 39-49 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 9107837 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity, comprising administering combinations of the bupropion (360mg) and naltrexone (32mg) in sustained release formulations in a single oral dosage or separately twice per day.
Nalpropion does not explicitly teach treating diabetes or auxiliary method steps like supplying dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
6. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 9125868 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity, comprising administering combinations of the bupropion (360mg) and naltrexone (32mg) in sustained release formulations in a single oral dosage or separately twice per day.
Nalpropion does not explicitly teach treating diabetes or auxiliary method steps like supplying dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
7. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-18 of U.S. Patent No. 9248123 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity through weight loss, comprising administering combinations of the bupropion (360mg) and naltrexone (32mg) in sustained release formulations in a single oral dosage or separately more than once per day.
Nalpropion does not explicitly teach treating diabetes or auxiliary method steps like supplying dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
8. Claims 31, 37, and 39-49 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-17 of U.S. Patent No. 9457005 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity and Type II diabetes comprising administering combinations of the same amounts of bupropion and naltrexone in sustained release formulations in a single oral dosage or separately as pills, capsules, or tablets to an obese patient with Type II diabetes. Additional steps include monitoring blood-glucose, changing dosage amounts, and providing dietary instructions. The patient is being treated with insulin and the amount used decreases following the administration of the claimed compounds.
Regarding particular percentage changes in insulin resistance and insulin amounts, "[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." See MPEP 2144.05 II (A).
Nalpropion does not teach anticonvulsant administration.
Weber teaches a method of administering the same combination and anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). It would be obvious to administer the third therapeutic in the Nalpropion method because Weber teaches its acceptability as an additional therapeutic.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat obesity, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
9. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-20 of U.S. Patent No. 10307376 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity through weight loss, comprising administering combinations of the bupropion (360mg) and naltrexone (32mg) in sustained release formulations in a single oral dosage as an oral tablet or pill.
Nalpropion does not explicitly teach treating diabetes or auxiliary method steps like supplying dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
10. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1 and 3-20 of U.S. Patent No. 10828294 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity in patients with Type II diabetes, comprising administering combinations of bupropion (360mg) and naltrexone (32mg) in sustained release formulations to (Type II) diabetic obese patients.
Nalpropion does not explicitly teach auxiliary method steps like supplying dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
11. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1 and 3-20 of U.S. Patent No. 10835527 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity in patients with Type II diabetes, comprising administering combinations of bupropion (360mg) and naltrexone (32mg) in sustained release formulations to (Type II) diabetic obese patients.
Nalpropion does not explicitly teach auxiliary method steps like supplying dietary instructions. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
12. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-19 of U.S. Patent No. 11033543 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion (360mg) and naltrexone (32mg) in sustained release formulations, single oral dosages, and multiple times per day.
Nalpropion does not teach the treatment of concomitant Type II diabetes. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
13. Claims 31, 37, and 40-53 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-5 and 7-15 of U.S. Patent No. 11139056 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion and naltrexone in sustained release formulations, single oral dosages, and multiple times per day.
Nalpropion does not teach the treatment of concomitant Type II diabetes or additional dosing modifications and auxiliary steps. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
14. Claims 31, 35, 37, and 39-49 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-7 of U.S. Patent No. 11278544 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating obesity comprising administering combinations of bupropion and naltrexone in sustained release formulations, single oral dosages, or separate doses.
Nalpropion does not teach the treatment of concomitant Type II diabetes. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
15. Claims 31, 35, 37, and 39-49 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-18 of U.S. Patent No. 11324741 (hereinafter referred to as Nalpropion) in view of Weber (WO2004096201, published 11/11/2004, 10/26/2010 IDS) and Hirsch (JAMA. 2003;289(17):2254–2264).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to a method of treating insulin resistance comprising administering combinations of the same amounts of bupropion (400mg) and naltrexone (32mg) in sustained release formulations in a single oral dosage.
Nalpropion does not teach the treatment of concomitant Type II diabetes. Nalpropion also does not teach that the patient to be treated is being administered insulin or that the insulin therapy is slowly reduced.
Weber teaches compositions for affecting weight loss and treating obesity and identifying patients in need thereof, i.e., with conditions disclosed by Weber (Abstract; Page 1). Regarding Claims 31, one composition includes 150mg of bupropion administered twice daily (300mg per day) and 50mg naltrexone every day (Page 34, Example 7, Group 3). Anticonvulsants including zonisamide are also administered (Page 6, Lines 24-27). The composition increases “the concentrations of α-MSH in the CNS by stimulating the release of α-MSH, suppressing its metabolism, reducing the antagonism of its interaction at MC3/4-R” which necessarily treats conditions like hyperinsulinemia; “deletion of the MC4-R gene produces obesity, hyperphagia, hyperinsulinemia, and reduced energy expenditure” as claimed in Claims 35 and 37 (Page 4, Lines 1-2; Page 2, Lines 35-36). Further, “Increased instances of complications such as…non-insulin dependent diabetes mellitus [Type II]…have been related to increased instances of obesity in the general population” (Page 1, Lines 8-12). One of ordinary skill in the art would expect the treatment of obesity to also treat the coincident condition of Type II diabetes, which shares a similar disease feature in dysregulated blood glucose levels. It would be obvious to use the Weber composition to treat a patient for obesity who also has additional complications like diabetes resulting therefrom because treatment of the obesity would necessarily treat the additional complication. Further, the treatment of hyperinsulinemia, a symptom associated with Type II diabetes, via the upregulation of MC4-R gene activity is tantamount to treatment of the disease Type II diabetes.
One embodiment of the composition includes 150mg of bupropion administered twice daily and 50mg naltrexone per day (Page 34, Example 7, Group 3). Alternate dose amounts of naltrexone include 25, 30, and 35 mg, which values fall within the naltrexone range of Claims 31 and 49 (Page 34, Lines 27-29). Regarding bupropion administered in amounts of 300mg daily, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05 (I). Further, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[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." See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II).
Similarly, Weber teaches the reduction of hyperinsulinemia a symptom or indicator of insulin resistance but not to a specific or quantified degree between 1% to 100%. However, “differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. ‘[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.’” See MPEP 2144.05 II (A). Regarding criticality, see MPEP 716.02(d) (II). Further, the claimed degree to which hyperinsulinemia is diminished would be expected as a result of performing the claimed method steps which are taught in Weber.
The compositions can be formulated for sustained release (a type of controlled release) as capsules, tablets, and pills for oral administration as described in Claims 44-48 (Page 23, Lines 4-13; Page 21, Lines 5-17). Patient glucose levels are monitored as in Claim 39 (Page 35, Lines 4-5). Dosages of the APIs may be adjusted to a series of two or more given in a single day rather than as a single dose or further adjusted as seen fit by a physician as recited in Claims 40 and 43 (Page 23, Line 25-Page 24, Line 24). It would therefore be obvious to the physician administering the composition to take into consideration the glucose levels or other “cardiovascular risk factors” when determining a route or dosage for future administration “in view of the patient’s condition” to mitigate risk to the cardiovascular system of the patient.
Weber does not explicitly teach separate administration of the claimed APIs or providing dietary instructions as in Claims 41-42. However, Weber teaches naltrexone and bupropion may be administered on different dosing schedules (QD and BID) which suggests that the APIs need not be administered together (Page 34, Example 7). Rather, Weber teaches that dosage forms and routes may be altered as seen fit by a practicing physician, making it obvious to one of skill in the art to administer each component separately expecting that the variable routes and dosage schedules will yield the same anti-obesity effects. With respect to dietary instructions, Weber teaches that the composition can affect eating habits. It would therefore be imperative to the medical practitioner to provide detailed dietary guidance to a receiving patient with the aim to promote healthy eating habits while on a medication altering said habits.
Hirsch teaches that insulin therapy is a well-known treatment of Type 2 diabetes (Abstract, Objective).
Therefore, one of skill in the art would seek to use the method of Weber comprising the anticonvulsant and bupropion-naltrexone combination to treat obesity and/or Type 2 diabetes in patients on the known insulin therapy regimen. The resultant treatment of hyperinsulinemia would permit decreased use of insulin administered to the patient as claimed because insulin is also used to treat Type 2 diabetes and conditions like hyperinsulinemia resulting therefrom. Although specific degrees of insulin therapy reduction are not taught, "[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." See MPEP 2144.05 II (A). The method of Nalpropion and Weber would therefore be expected to enable the reduction of necessary insulin treatment as claimed because both therapies are directed to treating the same conditions before the effective filing date of the examined claims.
Since both claim sets teach a method of administering combinations of bupropion and naltrexone to treat related conditions, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Nalpropion.
Conclusion
No claim is allowable.
Inquiries
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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