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.
Applicant traverses the rejection of claims. As argued by Applicant, “[a]ccording to the Office Action, Wilcox teaches the claimed patient population, stating that ‘[a] previous smoking cessation study that did not specifically target overweight or obese smokers demonstrated similar results with the naltrexone/bupropion combination’... it would have been prima facie obvious to extend the method of Wilcox et al to a patient that is not overweight or obese” (Applicant Arguments, Pages 7-8). However, as further argued by Applicant, although Wilcox et al indicate that the previous study “did not specifically target overweight or obese smokers... [the previous study] didn’t necessarily omit overweight subjects” (Applicant Arguments, Page 8).
Applicant is correct that the study cited by Wilcox et al did not necessarily omit overweight subjects. However, given that the “weight-concerned smokers [had a] baseline weight [of] 72 + 13 kg” (Page 233, Column 1), it is also evident that the study included patients having a BMI of less than 25 kg/m2.
Applicant next argues that “claim 54 specifically recites ‘wherein the patient does not consume a high-fat meal within 60 minutes of administering the unit dosage forms’” and “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 8).
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 with food that is not a high-fat meal, 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 9; see also Applicant Arguments, Page 10: “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 9). 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 9).
While it is recognized that the claimed food effect requires 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 9). 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 9).
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 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, 10,231,962, 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, 10,231,962, 10,307,376, 10,322,121 and 11,033,543 are MAINTAINED.
Claim Rejections - 35 USC § 112
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 76-77 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contain 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(s), at the time the application was filed, had possession of the claimed invention.
The response filed 3/10/2026 has introduced NEW MATTER into the claims. New claims 76-77 are directed to the method of claims 54 and 77, respectively, “wherein the patient has a BMI of less than 18.5 kg/m2”.
The Specification states that “[o]besity has been defined in terms of body mass index (BMI). BMI is calculated as weight (kg)/[height (m)]2. According to the guidelines of the U.S. Centers for Disease Control and Prevention (CDC), for adults over 20 years old, BMI falls into one of the following categories: below 18.5 is considered underweight, 18.5-24.9 is considered normal, 25.0-29.9 is considered overweight, and 30.0 and above is considered obese” (Paragraph 0072). The Specification further states, “[i]n some embodiments, the individual has a body mass index (BMI) of at least 25 kg/m2. In some embodiments, the individual has a BMI of at least 30 kg/m2. In some embodiments, the individual has a BMI of at least 40 kg/m2. In some embodiments, the individual has a BMI of less than 25 kg/m2, or develops a BMI less than 25 kg/m2 during the course of administration of naltrexone and bupropion” (Paragraph 0073)
The disclosure in the Specification that a BMI of “below 18.5 is considered underweight” and/or that “[i]n some embodiments, the individual has a BMI of less than 25 kg/m2” does not support the limitation in claims 76 and 77 that the patient has a BMI of less than 18.5 kg/m2. The recitation that the patient has a BMI of less than 18.5 kg/m2 changes the scope of the instant disclosure as filed and introduces new concepts which violate the description requirement of the first paragraph of 35 U.S.C 112.
Applicant is required to provide sufficient written support for the limitations recited in present claims in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
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, 57, 59-60, 62-65, 67-68, 70-71 and 74 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 Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record).
As amended, claims 54 and 71 (drafted independently) are each drawn to a method of administering naltrexone as an aid for smoking cessation treatment to a patient in need thereof (more specifically, not for the treatment of weight loss (claims 57 and 74)), the method comprising:
orally administering one or more pharmaceutical compositions/unit dosage forms comprising a sustained release formulation of naltrexone or a salt thereof (in an amount of about 8 mg to about 32 mg per day) to a patient in need thereof, wherein the patient has a BMI of less than 25 kg/m2;
wherein:
(a) the patient does not consume a high-fat meal within 60 minutes of administering the pharmaceutical composition, and
(b) the patient’s AUC and Cmax for naltrexone does not increase by about 2.1-fold and about 3.7-fold, respectively, compared to administering the one or more compositions with a high-fat meal.
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), wherein the “drug was to be taken with food” (Page 230, Column 1) wherein, “[a]t Week 12, subjects were counseled to follow a hypocaloric diet” (Page 230, Figure 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).
However, Wilcox et al do not teach:
(a) administration of to a patient having a BMI of less than 25 kg/m2; or
(b) administration wherein the patient does not consume a high-fat meal within 60 minutes of administering the pharmaceutical composition and thereby avoiding an increase in AUC and Cmax for naltrexone of about 2.1-fold and about 3.7-fold, respectively.
Yet, as to (a): as taught by Wilcox et al, “weight gain [is a] common deterrent to smoking cessation, and post-cessation weight gain has been associated with relapse” (Page 229, Column 2). 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 method of Wilcox et al to a patient that is not overweight or obese. It would have been obvious to do so in order to minimize post-cessation weight gain as a deterrent in nonobese patients desiring to quit smoking, mitigate weight gain associated with the cessation of cigarette smoking in nonobese patients concerned about post-cessation weight gain, and/or to reduce the likelihood of smoking relapse in nonobese patients that experience post-cessation weight gain, with a reasonable expectation of success.
And, as to (b): as taught by Jequier et al, “low-fat diets are preferred to limit excessive weight gain” and “are also advocated to lower the risk of coronary heart disease and certain forms of cancer” (Abstract). As further as taught by Jequier et al, “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 a ensure said nonobese patient being treated for smoking cessation follow a low-fat diet. It would have been obvious to do so in order to further minimize post-cessation weight gain as a deterrent in nonobese patients desiring to quit smoking, mitigate weight gain associated with the cessation of cigarette smoking in nonobese patients concerned about post-cessation weight gain, and/or to reduce the likelihood of smoking relapse in nonobese patients that experience post-cessation weight gain, with a reasonable expectation of success.
Furthermore, in doing so, it is asserted that the claimed increases in AUC and Cmax for naltrexone would necessarily be avoided. As noted by the court in Hoffer v. Microsoft Corp., 405 F.3d 1326 (Fed. Cir. 2005), a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003)).
In view of all of the foregoing, claims 54, 57, 71-72 and 74 are rejected as prima facie obvious.
Claim 59 is drawn to the method of claim 54 wherein the sustained release formulation of naltrexone is a non-sequestered sustained release formulation.
Although it is recognized that “[i]nherency may not be established by probabilities or possibilities” (In re Robertson, 169 F.3d 743 (Fed. Cir. 1999)), Applicant is also reminded 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. When, as here, 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). In the instant case, the claimed and prior art methods are substantially identical and there is nothing to suggest that the sustained release formulation of naltrexone administered according to the method of Wilcox et al is a sequestered sustained release formulation. As such, absent evidence to the contrary, it is asserted that sustained release formulation of naltrexone administered according to the method of Wilcox et al is a non-sequestered sustained release formulation, as recited by claim 59 (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”).
Accordingly, claim 59 is also rejected as prima facie obvious.
Claim 60 is drawn to the method of claim 59 wherein at least 50% of the naltrexone is released within 24 hours of administration.
For largely the same reasons as discussed above regarding claim 59, it is asserted (absent evidence to the contrary) that administration of the pharmaceutical composition comprising naltrexone SR/bupropion SR according to the method of Wilcox et al would release at least 50% of the naltrexone within 24 hours of administration. As noted by the court in Hoffer v. Microsoft Corp. (405 F.3d 1326 (Fed. Cir. 2005)), a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited” (quoting Minton v. Nat ' l Ass ' n of Securities Dealers, Inc., 336 F.3d 1373 (Fed. Cir. 2003))
Accordingly, claim 60 is also rejected as prima facie obvious.
Claim 62 is drawn to the method of claim 54 wherein the one or more pharmaceutical compositions are administered according to a daily treatment schedule comprising:
about 8 mg naltrexone for the first week of treatment;
about 16 mg naltrexone for the second week of treatment;
about 24 mg naltrexone for the third week of treatment; and
about 32 mg naltre`xone for the fourth and any subsequant weeks of treatment.
Wilcox et al teach administration of “natrexone SR (8 mg) … 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).
Accordingly, claim 62 is also rejected as prima facie obvious.
Claims 63-64 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 (claim 63), more specifically administered as two tablets twice daily (claim 64).
Wilcox et al teach administration of a “formulation of natrexone SR (8 mg)… as … 2 tablets BID” (Page 230, Column 1).
Accordingly, claims 63-64 are also rejected as prima facie obvious.
Claim 65 is drawn to the method of claim 54 – wherein claim 54 recites a method of administering “one or more pharmaceutical compositions comprising a sustained release formulation of naltrexone or a pharmaceutically acceptable salt thereof and a sustained release formulation of bupropion or a pharmaceutically acceptable salt thereof” – wherein, as recited by claims 65-66 “the naltrexone salt comprises naltrexone hydrochloride”.
As such, claim 65 further limits the pharmaceutically acceptable salts of claim 54 without requiring said limitation.
Accordingly, claim 65 is also rejected as prima facie obvious.
Claims 67-68 and 70 are drawn to the method of claim 54, wherein the one or more pharmaceutical compositions are administered in a single oral unit dosage form (claim 67), more specifically administered two or more times per day (claim 64), in the form of a tablet (claim 70).
Wilcox et al teach administration of a “formulation of natrexone SR (8 mg)… as … 2 tablets BID” (Page 230, Column 1).
Accordingly, claims 67-68 and 70 are also rejected as prima facie obvious.
Claims 59-60 are rejected, in the alternative, 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 Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record) as applied to claims 54, 57, 59-60, 62-65, 67-68, 70-71 and 74 above, in further view of McKinney et al (US 2007/0281021; of record).
Claims 59-60 are drawn to the method of claim 54 wherein the sustained release formulation of naltrexone is a non-sequestered sustained release formulation (claim 59), more specifically, wherein at least 50% of the naltrexone is released within 24 hours of administration (claim 60).
As such, the method of Wilcox et al differs from the instantly claimed method in that Wilcox et al does not specify 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.
Yet, McKinney et al teach “[a] sustained-release oral dosage form of naltrexone” (Abstract) as a tri-layer tablet wherein at least 50% of the naltrexone is released within 24 hours of administration (Paragraphs 0105-0106).
It would have been prima facie obvious to substitute one known naltrexone SR dosage form (i.e., a tri-layer tablet, as taught by McKinney et al) in place of the naltrexone SR tablet taught by 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 such, claims 59-60 are also rejected as prima facie obvious.
Claim 69 is 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 Jequier et al (Am J Med 113(9B):41S-46S, 2002; of record) as applied to claims 54, 57, 59-60, 62-65, 67-68, 70-71 and 74 above, in further view of McKinney et al (US 2007/0281021; of record).
Claim 69 is drawn to the method of claim 67 (which depends from claim 54), wherein the single oral unit dosage form comprising naltrexone SR which is administered is a capsule.
As discussed above, Wilcox et al teach administration of a “formulation of natrexone SR (8 mg)” as a “tablet” (Page 230, Column 1).
As such, the method of Wilcox et al differs from the instantly claimed method in that Wilcox et al does not teach administration of the single oral unit dosage form comprising naltrexone SR + bupropion SR as a capsule.
Yet, McKinney et al teach “[a] sustained-release oral dosage form of naltrexone… [which] may be administered with another compound” (Abstract), in particular a “[n]altrexone SR/bupropion SR… capsule” (Paragraph 0128).
It would have been prima facie obvious to substitute one known naltrexone SR dosage form (i.e., a capsule, as taught by McKinney et al) in place of the naltrexone SR tablet taught by 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”).
Accordingly, claim 69 is also rejected as prima facie obvious.
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, 59-60, 62-65, 67-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9,248,123.
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) – more specifically according to the regimen of instant claim 62 (claim 10) in sustained release (claim 11).
Claims 54, 59-60, 63-65, 67-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,231,962.
Although the claims at issue are not identical, they are not patentably distinct from each other. The ‘962 claims similarly recite a method comprising administering naltrexone (about 4 to about 50 mg/day) – more specifically, in sustained release (claim 8).
Claims 54, 57, 59-60, 62-65, 67-68, 70-71 and 74 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,307,376.
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) according to the regimen of instant claim 62, 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).
Claims 54, 59-60, 62-65, 67-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,322,121.
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) – more specifically according to the regimen of instant claim 62 (claim 6) in sustained release (claim 7).
Claims 54, 59-60, 62-65, 67-68 and 71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,033,543.
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) – more specifically according to the regimen of instant claim 62 (claim 12) in sustained release (claim 13).
Conclusion
The new ground(s) of rejection presented in this Office action are necessitated by Applicant’s amendments to the claims. 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.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611