DETAILED ACTION
Notice of Pre-AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
The amendments filed 3/10/2026 have been entered.
Response to Arguments
Applicant’s arguments, filed 3/10/2026, have been fully considered.
As discussed in the basis of the rejection, based on U.S. Dept of Health and Human Services and Wellbutrin Prescribing Information, it would have been obvious to administer the combined formulation of naltrexone SR (8 mg)/bupropion SR (90 mg) taught by Wilcox et al with food (i.e., within 60 minutes of consuming food) in an effort to reduce nausea (i.e., the most frequent adverse event associated with said naltrexone/bupropion combination therapy) with a reasonable expectation of success. And, based further on Jequier et al, it would have been obvious to do so wherein said food is not a high-fat meal “as an important goal for prevention of obesity” in said patients.
Applicant, however, argues that “neither the Office Action nor Jequier disclose a connection between naltrexone administration and not consuming high-fat meals within 60 minutes of said administration” (Applicant Arguments, Page 6). Namely, that “it was surprisingly found that administering a sustained release formulation of naltrexone in combination with a high-fat meal, within 60 minutes of administration, led to a significant change in the plasma pharmacokinetics of naltrexone” (Applicant Arguments, Page 6). And, as further argued by Applicant, “[n]one of Toll, HHS, or Wellbutrin disclose, teach, or suggest a method where a patient does not consume a high-fat meal within 60 minutes of administering the one or more pharmaceutical composition or the patient’s AUC or Cmax does not increase by 2.1-fold and 3.7-fold respectively” (Applicant Arguments, Page 9).
It is acknowledged that the prior art do not disclose the food effect itself (i.e., an increase in AUC and Cmax for naltrexone of about 2.1-fold and about 3.7-fold, respectively, when administered with a high-fat meal and/or its avoidance) or a connection between (a) the steps of administering naltrexone and consuming food that is not a high-fat meal within 60 minutes of said administration, and (b) avoiding the food effect. Nevertheless, the claimed method was rejected on the grounds that the recited food effect and/or its avoidance is merely an inherent property of the prima facie obvious administration of the prior art composition. As discussed previously, in In re Kao, 639 F.3d 1057 (Fed. Cir. 2011), which involved claims drawn to a method for treating pain comprising administering oxymorphone to a subject in need thereof, “wherein the… Cmax is at least about 50% higher when the dosage is administered to the subject under fed versus fasted conditions”, the court found that “the claimed ‘food effect’ is an inherent property of oxymorphone itself” wherein “the claimed ‘food effect’ adds nothing of patentable consequence”.
Yet, as argued by Applicant, “[r]egarding In re Kao, the claims recited a formulation of oxymorphone with a food effect wherein Cmax was greater than or equal to 50% higher in fed versus fasted conditions” wherein “[t]he prior art disclosed the same formulation but did not mention the food effect” (Applicant Arguments, Page 7; see also Applicant Arguments, Page 8: “the claims of In re Kao recited a formulation, whereas the claims in the present application recite a method”).
The argument is not found persuasive. On appeal in In re Kao were the rejections of three patent applications, U.S. Patent Application Nos. 11/680,432, 12/167,859 and 11/766,859. While the ‘432 Application was directed to “[a]n analgesically effective controlled release pharmaceutical composition”, the ‘859 and ‘740 Applications were drawn to methods. In particular, the ‘859 Application recited “[a] method for treating pain in a human subject... comprising... (a) providing a solid oral dosage form comprising about 5 mg to about 80 mg oxymorphone... in a controlled release delivery system... and (b) administering the dosage form to the subject, wherein the oxymorphone Cmax is at least about 50% higher when the dosage form is administered to the subject under fed versus fasted conditions”.
Applicant, however, further argues that, in In re Kao, “[t]he Federal Circuit held that the formulation itself was obvious from the prior art and that the food effect was an inherent property of the oxymorphone, not a property created by the claimed formulation. Therefore, the limitation adds nothing of patentable consequence” (Applicant Arguments, Page 7). Yet, “[i]n contrast to Kao, the present application does not admit that the claimed pharmacokinetic effect is inherent to the active ingredient itself. Instead, the claimed pharmacokinetic effect is a result of a specific combination between the pharmaceutical (e.g., naltrexone) and a high-fat meal consumed within 60 minutes of the naltrexone administration” (Applicant Arguments, Page 7).
While it is recognized that the claimed food effect requires the consumption of food to precipitate said effect, it remains the case that the food effect is inherent to the pharmaceutical formulation.
Applicant next argues that “if the food effect is larger than expected... i.e., an unexpected result... then it can support non-obviousness” and, “[u]nexpected PK profiles can overcome inherency arguments where the unexpected result has a ‘nexus to some aspect of the claim’” citing In re Kao (Applicant Arguments, Page 7). As argued by Applicant, the “claimed invention shows that high-fat meals dramatically increase AUC and Cmax for naltrexone treatment, clearly showcasing a nexus between the unexpected results and the claimed method” (Applicant Arguments, Page 8).
Indeed, as stated in In re Kao, “[f]or objective evidence of secondary conditions to be accorded substantial weight, its proponent must establish a nexus between the evidence and the merits of the claimed invention”. However, “where the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention”. As further discussed in In re Kao, addressing the ‘432 Application directed to the composition, “for the unexpected in vivo concentration profile of the applicant’s product to have substantial weight, there must be a nexus to some aspect of the claim not already in the prior art, such as the claimed range of dissolution rates, as against other unclaimed prior-art dissolution rates”.
In the instant case, as set out in the basis of the rejection, the prior art collectively teach the administration of the instantly claimed composition to the instantly claimed patient population in the instantly claimed amount and according to the instantly claimed dosing regimen with food wherein the food is not a high-fat meal. As such, there is no nexus between the alleged unexpected result and some aspect of the claim that is not already in the prior art.
Lastly, Applicant traverses the rejections of claims on the grounds of non-statutory double patenting over U.S. Patent Nos. 9,248,123, 10,307,376, 10,322,121, 11,033,543, 10,403,170, 11,139,056 and 11,279,544 and co-pending Application No. 17/717,691.
The rejections based on 10,403,170, 11,139,056 and 11,279,544 are WITHDRAWN.
The rejections based on U.S. Patent Nos. 9,248,123, 10,307,376, 10,322,121 and 11,033,543 are MAINTAINED.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 54-55, 57, 59-60 and 63 are rejected under 35 U.S.C. 103(a) as being unpatentable over Wilcox et al (Addict Behav 35(3):229-234, 2010 – published online 10/31/2009; of record) in view of Toll et al (Addictive Behaviors 33:173-179, 2008; of record), McKinney et al (US 2007/0281021; of record), U.S. Dept of Health and Human Services (the facts about Naltrexone for Treatment of Opioid Addiction, 2009; of record), Wellbutrin Prescribing Information (bupropion hydrochloride, June 2009; of record) and Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record).
Claim 54 is drawn to a method of administering naltrexone, the method comprising:
orally administering one or more pharmaceutical compositions comprising a sustained release formulation of naltrexone HCl (in an amount of about 8 mg to about 32 mg per day) to a patient in need thereof (more specifically, a patient with a BMI of at least 25 kg/m2 (claim 55));
wherein the sustained release formulation of naltrexone HCL is a non-sequestered sustained release formulation wherein at least 50% of the naltrexone is released within 24 hours of administration;
wherein the one or more pharmaceutical compositions are administered according to a daily treatment schedule comprising:
about 8 mg naltrexone HCl for the first week of treatment;
about 16 mg naltrexone HCl for the second week of treatment;
about 24 mg naltrexone HCl for the third week of treatment; and
about 32 mg naltrexone HCl for the fourth and any subsequent weeks of treatment;
wherein the patient is administered about 32 mg of naltrexone HCl for at least 12 weeks and the patient loses at least 5% of initial body weight after 12 weeks;
wherein the one or more pharmaceutical compositions are administered within 60 minutes of consuming food that is not a high-fat meal;
wherein the patient does not consume a high-fat meal within 60 minutes of administering the one or more pharmaceutical compositions; and
wherein said administering without a high-fat meal avoids an increase in AUC and Cmax for naltrexone of about 2.1-fold and about 3.7-fold, respectively.
Wilcox et al teach administering “[a] combination of sustained release (SR) naltrexone (32 mg/day) and bupropion SR (360 mg/day)… for the treatment of smoking cessation and mitigation of nicotine withdrawal and weight gain” to “[t]hirty overweight or obese” (Abstract), i.e., a patient having “a body mass index (BMI) > 27 and < 45 kg/m2” (Page 230, Column 1), and report that “[i]n overweight or obese smokers, naltrexone/bupropion combination therapy… was associated with decreased nicotine use, limited nicotine withdrawal symptoms, and no significant weight gain” (Abstract). Specifically, Wilcox et al teach administration of the “formulation of naltrexone SR (8 mg)/bupropion SR (90 mg) … to be taken with food as follows: 1 tablet in the morning during Week 1, 1 tablet in the morning and 1 tablet in the evening during Week 2, 2 tablets in morning and 1 tablet in evening during Week 3, and 2 tablets BID thereafter” (Page 230, Column 1) for at least 24 weeks.
However, Wilcox et al do not teach:
(a) administration of naltrexone HCl;
(b) that the sustained release formulation of naltrexone is a non-sequestered sustained release formulation wherein at least 50% of the naltrexone is released within 24 hours of administration;
(c) administration within 60 minutes of consuming food that is not a high-fat meal, wherein the patient does not consume a high-fat meal within 60 minutes of administering the one or more pharmaceutical compositions, and wherein said administering without a high-fat meal avoids an increase in AUC and Cmax for naltrexone of about 2.1-fold and about 3.7-fold, respectively; or
(d) that the patient loses at least 5% of initial body weight after 12 weeks.
Yet, as to (a): Wilcox et al teach the administration of naltrexone and buproprion wherein each tablet comprises about 8 mg of naltrexone and 90 mg of bupropion – but are silent as to the salt forms of naltrexone and buproprion.
Toll et al – which similarly teach the administration of naltrexone and buproprion “to stop smoking with less weight gain” (Title) – disclose naltrexone hydrochloride and bupropion hydrochloride (Abstract).
In view of Toll et al, it would have been prima facie obvious to utilize the hydrochloride salts of naltrexone (and bupropion) in the method of Wilcox et al (see Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356 (Fed. Cir. 2012): finding a “strong case of obviousness based on the prior art references of record [wherein the claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
As to (b): McKinney et al teach “[a] sustained-release oral dosage form of naltrexone” which “may be administered with another compound” (Abstract), in particular wherein “the second compound comprises… bupropion” (Paragraph 0015), wherein the oral dosage form has an in vitro release rate as determined by standard dissolution tests wherein at least 50% of the naltrexone is released within 24 hours (see Figures 1-3).
At the outset, it is noted that McKinney et al is assigned to Orexigen Therapeutics, Inc., which is the same company that supplied naltrexone SR in the study of Wilcox et al. As such, it is reiterated that, since the prior art appears to contain the exact same elements as those instantly claimed, the burden is properly shifted to Applicant to show otherwise. As stated in In re Best, Bolton, and Shaw, “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product" 562 F2d 1252 (CCPA 1977).
Yet, even assuming arguendo that Applicant can prove that the naltrexone SR utilized by Wilcox et al is not a non-sequestered formulation as claimed, it would have been prima facie obvious to a person of ordinary skill in the art to modify the method of Wilcox et al so as to utilize the non-sequestered naltrexone SR formulation of McKinney et al. The simple substitution of one known naltrexone SR formulation for another known naltrexone SR formulation is prima facie obvious.
As to (c): as taught by Wilcox et al, “[n]altrexone/bupropion combination therapy was generally well tolerated” although “[n]ausea was the most frequent adverse event” (Page 232, Column 2), reported in 37.9% of patients.
As taught by U.S. Dept of Health and Human Services, discussing common side effects of naltrexone and simple ways to reduce them, “[u]pset stomach or vomiting – Take the pill with food or after a meal” (Page 7).
And as taught by Wellbutrin Prescribing Information, “[i]f you have nausea, take your medicine with food” (Page 27 of 29).
Accordingly, in further view of U.S. Dept of Health and Human Services and Wellbutrin Prescribing Information, it would have been obvious to administer the combined formulation of naltrexone SR (8 mg)/bupropion SR (90 mg) taught by Wilcox et al with food (i.e., within 60 minutes of consuming food). It would have been obvious to do so in an effort to reduce nausea (i.e., the most frequent adverse event associated with said naltrexone/bupropion combination therapy) with a reasonable expectation of success.
Furthermore, it would have been obvious to do so wherein said food is not a high-fat meal based on Jequier et al. As taught by Jequier et al, “[b]ecause even a modest weight loss in obese subjects is accompanied by an improved insulin sensitivity and a decrease in impaired glucose tolerance, it is appropriate from a public health perspective to promote a reduction in total fat intake as an important goal for the prevention of obesity and obesity-induced diabetes” (Page 43S, Column 2). Significantly, “low-fat diets have been consistently shown to promote moderate weight loss over 1 year” (Page 43S, Column 2).
Accordingly, in further view of Jequier et al, it would have been prima facie obvious to ensure the overweight or obese smokers treated according to the method of Wilcox et al were on a low-fat diet. It would have been obvious to do so in an effort to promote weight loss in said patients with a reasonable expectation of success.
Additionally, regarding the recitation that said administering without a high-fat meal avoids an increase in AUC and Cmax for naltrexone of about 2.1-fold and about 3.7 fold, respectively, while the fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic (In re Rijckaert, 9 F.3d 1531 (Fed. Cir. 1993); see also In re Robertson, 169 F.3d 743 (Fed. Cir. 1999), “[i]nherency may not be established by probabilities or possibilities”), it is well settled that “inherency may supply a missing claim limitation in an obviousness analysis” so long as “the limitation at issue necessarily must be present or the natural result of the combination of elements explicitly disclosed by the prior art” (PAR Pharm., Inc. v. TWI Pharm., Inc. 773 F.3d 1186 (Fed. Cir. 2014)). “If… the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient” (quoting In re Oelrich, 666 F.2d 578 (C.C.P.A. 1981). Thus, as stated by the court in PAR Pharm., Inc. v. TWI Pharm., Inc., “inherency... is present… when the limitation at issue is the ‘natural result’ of the combination of prior art elements” (Id.). And, as stated by the court in In re Dillon (919 F.2d 688 (Fed. Cir. 1990)), “it is not necessary in order to establish a prima facie case of obviousness… that there be a suggestion in or expectation from the prior art that the claimed [invention] will have the same or similar utility as one newly discovered by applicant”.
While the court in PAR Pharm., Inc. v. TWI Pharm., Inc. further indicates that “the concept of inherency must be limited when applied to obviousness” and “[a] party must… meet a high standard in order to rely on inherency to establish the existence of a claim limitation in the prior art in an obviousness analysis”, it must also be remembered that the U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent Applicant may present previously unmeasured characteristics. As such, a prior art disclosure of a product or method “appearing to be substantially identical” to that instantly claimed, and rationale or evidence “tending to show inherency”, shifts the burden to the Applicant to prove otherwise (MPEP 2112 (IV)-(V)). As stated in In re Best, Bolton, and Shaw (562 F2d 1252 (CCPA 1977)), “[w]here… the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product” (see also In re Fitzgerald 619 F2d 67 (CCPA 1980): the burden is shifted to the applicants to “prove that subject matter shown to be in the prior art does not possess characteristic relied on”).
This is especially true in cases where the newly discovered, inherent limitation is claimed functionally rather than structurally. For example, in In re Kubin (561 F.3d 1351 (Fed. Cir. 2009)), discussing claims drawn to an isolated nucleic acid molecule encoding a polypeptide “wherein the polypeptide binds CD48”, the court stated that there is “no obligation to predicate [an] obviousness finding on factual findings regarding a prior art teaching of [the polypeptide’s] binding to the CD48 protein” – the limitation is “not an additional requirement imposed by the claims on the [polypeptide], but rather a property necessarily present in” the polypeptide. As stated by the court in Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 (Fed. Cir. 2012), “[t]o hold otherwise would allow any formulation – no matter how obvious – to become patentable merely by testing and claiming an inherent property” (discussing claims drawn to methods of administering an active agent “wherein upon oral administration… an initial serum concentration of the [active agent] greater than about 0.1 µg / ml is obtained at any time within about 30 minutes after administration” and further noting that “[t]he initial blood serum concentration resulting from administering [the active agent] is an inherent property of the formulation, and an obvious formulation cannot become nonobvious simply by administering it to a patient and claiming the resulting serum concentrations”).
In the instant case, the claimed and prior art products are substantially identical and are administered according to an identical dosing regimen to an identical patient population, wherein it would have been prima facie obvious to carry out said administration within 60 minutes of consuming food that is not a high-fat meal and wherein the patient does not consume a high-fat meal within 60 minutes of administering the one or more pharmaceutical compositions. As such, absent evidence to the contrary, it is asserted that said administration would necessarily avoid the recited increases in AUC and Cmax. As stated by the court in Ex parte Obiaya (227 USPQ 58 (Bd. Pat. App. & Int. 1985), “[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis of patentability when the differences would otherwise have been obvious” (see also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446 (Fed. Cir. 1989), “The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention”).
And, as to (d): For largely the same reasons as discussed regarding (c) above, it is also asserted – absent evidence to the contrary – that the prima facie obvious method (i.e., comprising administering naltrexone in combination with a low-fat diet) would result in a loss of at least 5% of initial body weight after 12 weeks. Indeed, Wilcox et al suggest the same, noting that “advice to follow a hypocaloric diet was begun at Week 12 and would not have affected the primary outcome” (Page 233, Column 1), implying that following a hypocaloric diet from the start would have resulted in more weight loss.
For all the foregoing reasons, claims 54-55 are rejected as prima facie obvious.
Claims 57 and 60 are drawn to the method of claim 54, wherein the one or more pharmaceutical compositions comprise a plurality of tablets each comprising about 8 mg of naltrexone HCl (claim 57), more specifically administered as two tablets twice daily (claim 60).
As discussed above, Wilcox et al teach administration of “a combined formulation of natrexone SR (8 mg)/bupropion SR (90 mg)… as … 2 tablets BID” (Page 230, Column 1).
Accordingly, claims 57 and 60 are also rejected as prima facie obvious.
Claim 59 is drawn to the method of claim 57 wherein administration of a single dose of two tablets in combination with a high-fat meal to a group of healthy adult volunteers provides certain outcomes.
It is noted that the claimed method is directed to the administration of naltrexone HCL in combination with food that is not a high-fat meal. As such, the outcomes recited by claim 59 (which are outside the claimed method) do not carry patentable weight.
As such, claim 59 is also rejected as prima facie obvious.
Claim 63 is drawn to the method of claim 54 wherein the patient is not overweight or obese.
Wilcox et al teach the administration of naltrexone and bupropion “for the treatment of smoking cessation and mitigation of nicotine withdrawal and weight gain” to “[t]hirty overweight or obese” (Abstract), i.e., a patient having “a body mass index (BMI) > 27 and < 45 kg/m2” (Page 230, Column 1), wherein it would have been obvious to combine said administration with food that is not a high-fat meal in further view of Jequier et al.
However, as further taught by Wilcox et al, citing Toll et al (which recognize “the fear of post-cessation weight gain” as a barrier in preventing “some cigarette smokers from attempting to quit” (Abstract)), “[a] previous smoking cessation study that did not specifically target overweight or obese smokers demonstrated similar results with the naltrexone/bupropion combination”, noting “[t]he attenuation of short-term weight gain in non-obese subjects” therein (Page 233, Column 1).
In view of the foregoing, it would have been prima facie obvious to extend the prima facie obvious method based primarily on Wilcox et al as discussed above to a patient that is not overweight or obese. It would have been obvious to do so in order to promote weight loss along with the cessation of cigarette smoking in patients that are concerned about post-cessation weight gain.
As such, claim 63 is also rejected.
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 §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 54-55, 57, 59-60 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,248,123 in view of McKinney et al (US 2007/0281021; of record), U.S. Dept of Health and Human Services (the facts about Naltrexone for Treatment of Opioid Addiction, 2009), Wellbutrin Prescribing Information (bupropion hydrochloride, June 2009) and Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘123 claims similarly recite a method comprising administering naltrexone (32 mg/day) and bupropion (360 mg/day) – more specifically according to the instantly claimed regimen (claim 10) in sustained release (claim 11).
It would have been obvious to administer the composition within 60 minutes of consuming food in an effort to reduce nausea, based on U.S. Dept of Health and Human Services and Wellbutrin Prescribing Information.
And, considering that the method of the ‘123 claims is directed to providing weight loss therapy to an overweight or obese patient, it would have been obvious to ensure said food is not a high-fat meal, based on Jequier et al.
Claims 54-55, 57, 59-60 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,307,376 in view of McKinney et al (US 2007/0281021; of record), U.S. Dept of Health and Human Services (the facts about Naltrexone for Treatment of Opioid Addiction, 2009), Wellbutrin Prescribing Information (bupropion hydrochloride, June 2009) and Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘376 claims similarly recite a method comprising administering naltrexone (about 8 mg/day) and bupropion (90 mg/day) according to the instantly claimed regimen, as a single oral dosage unit (claim 4) as a tablet or capsule (claim 5) in multiple doses (claims 3, 6, 7 and 8) in sustained release form (claim 9).
It would have been obvious to administer the composition within 60 minutes of consuming food in an effort to reduce nausea, based on U.S. Dept of Health and Human Services and Wellbutrin Prescribing Information.
And, considering that the method of the ‘376 claims is directed to providing weight loss, it would have been obvious to ensure said food is not a high-fat meal, based on Jequier et al.
Claims 54-55, 57, 59-60 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,322,121 in view of U.S. Dept of Health and Human Services (the facts about Naltrexone for Treatment of Opioid Addiction, 2009), Wellbutrin Prescribing Information (bupropion hydrochloride, June 2009) and Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘121 claims similarly recite a method comprising administering naltrexone (about 4 to about 50 mg/day) and bupropion (about 30 to about 500 mg/day) – more specifically according to the instantly claimed regimen (claim 6) in sustained release (claim 7).
It would have been obvious to administer the composition within 60 minutes of consuming food in an effort to reduce nausea, based on U.S. Dept of Health and Human Services and Wellbutrin Prescribing Information.
And, considering that the method of the ‘121 claims is directed to treatment in patients who are overweight or obese, it would have been obvious to ensure said food is not a high-fat meal, based on Jequier et al.
Claims 54-55, 57, 59-60 and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,033,543 in view of U.S. Dept of Health and Human Services (the facts about Naltrexone for Treatment of Opioid Addiction, 2009), Wellbutrin Prescribing Information (bupropion hydrochloride, June 2009) and Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record).
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘543 claims similarly recite a method comprising administering naltrexone (about 4 to about 50 mg/day) and bupropion (about 30 to about 500 mg/day) – more specifically according to the instantly claimed regimen (claim 12) in sustained release (claim 13).
It would have been obvious to administer the composition within 60 minutes of consuming food in an effort to reduce nausea, based on U.S. Dept of Health and Human Services and Wellbutrin Prescribing Information.
And, considering that the method of the ‘543 claims is directed to providing weight loss, it would have been obvious to ensure said food is not a high-fat meal, based on Jequier et al.
Claims 54-55, 57-60 and 63-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 54-75 of copending Application No. 17/717,691.
The ‘691 application similarly recites a method comprising administering naltrexone SR and bupropion SR – more specifically according to the instantly claimed regimen (claim 62) in the absence of a high-fat meal to avoid the instantly claimed increases in AUC and Cmax.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No new ground(s) of rejection are presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611