DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Application Status
The amendment filed on 7/06/2026 in response to the Non-Final Rejection of 2/05/2026 is acknowledged and has been entered.
Claims 1, 13-17, 19-22 and 25-27 are currently pending and under consideration.
Rejections Maintained
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 13-17, 19-22 and 25-27 remain rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al. (US Patent No. 9,545,426B2, 2017-01-17) in view of Celio et al. (Obesity Surgery (2019) 29: 858-861, published online 2018-12-18).
(Note: The above rejection has been modified to replace Cello et al. with Celio et al.. The Examiner appreciates Applicants for pointing this out)
Gilbert et al. teach a method for the prevention and/or treatment of post operative nausea and vomiting, wherein said method comprises administering amisulpride at a dose of 1 mg to 20 mg to a subject of a surgical procedure and in need of such prevention and/or treatment (claim 1 of Gilbert). With regards to the surgical procedure, the US patent teaches that the surgical procedure is chosen from procedures of the eye or ear, laparoscopic cholecystectomy, hysterectomy, breast surgery, abdominal surgery and gynecological surgery (claim 16 of Gilbert). With regards to amisulpride, the US patent teaches that substantially pure enantiomer or non-racemic mixtures may be used, but it may be preferred to use the racemate or (S-) amisulpride (column 3, lines 4-7 and claim 25 of Gilbert). With regards to the dose of amisulpride, the US Patent teaches that amisulpride is given at a dose of 2.5 mg, 5 mg or 20 mg and as a single dose (claims 12-14 of Gilbert, column 7, lines 50-52). With regards to the routes of administration, the US patent teaches that the compound is administered via intravenous injection (claim 17 of Gilbert). With regards to the subject, the US Patent teaches that subject is human and further has received an anesthetic (claims 5 and 15 of Gilbert). Moreover, the US Patents teaches that amisulpride is administered in combination with another anti-emetic drug, wherein the anti-emic drug is a 5HT3 antagonist such as ondansetron or dexamethasone claims 7-10 of Gilbert and column 4, lines 60-67).
The US patent does not teach that the surgery is bariatric surgery, wherein the patient has a BMI of >=30 or >=35. Nor does the US patent teach that amisulpride is administered via IV infusion over from about 1 to about 2 minutes or a dose of about 10 mg.
Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV) and compares the incidence and severity of PONV between patients undergoing laparoscopic sleeve (SG) and gastric bypass (GB) (Abstract). Celio teaches that there was no significant difference in two populations, for example, BMI (46.9 +/- 6.1 vs. 50.5 +/- 10.1) (page 859, 2nd column, 1st full paragraph). In conclusion, Celio et al. teach that PONV is particularly important in bariatric patients as it is a major contributor towards readmission and dehydration with no significant difference in PONV between the two most commonly performed weight loss procedures (page 861, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include a patient undergoing bariatric surgery in the method taught by Gilbert et al. in view of the teachings of Celio et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Gilbert et al. teach that amisulpride is useful at preventing and/or treating post operative nausea and vomiting during a surgical procedure, and
- Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV).
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include optimize the amount and administration timing in the method taught by Gilbert et al.. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
- Gilbert et al. teach that amisulpride is useful at preventing and/or treating post operative nausea and vomiting during a surgical procedure in a dosage ranging from 1 mg to 20 mg, and
-The route of administration may depend on the condition being treated, for example, amisulpride can be formulated with morphine in an infusion bag (column 5, lines 5-13).
Generally, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In response to this rejection, Applicants contend that Gilbert does not describe prophylactically treating the recited patient population and Celio is merely cited for it disclosure that PONV rates are similar between patients undergoing laparoscopic sleeve gastrectomy and gastric bypass, but makes no mention of the use of amisulpride. As such, Applicants contend that the Office has not established that a person of ordinary skill in the art would have reasonably predicted that the claimed methods of administering 5-20 mg of amisulpride would prophylactically treat PONV in high BMI patients.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case and as set forth above, Gilbert et al. teach that amisulpride is useful at preventing and/or treating post operative nausea and vomiting during a surgical procedure, and Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV). Accordingly, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include a patient undergoing bariatric surgery in the method taught by Gilbert et al. in view of the teachings of Celio et al..
Applicants further contend that the Examiner’s rationale appears to assume that any known antiemetic useful in generic surgical population would be expected to function similarly in high-BMI bariatric patients, without addressing the physiological differences, altered pharmacokinetics, and distinct PONV risk in the subset.
In response to these arguments, the examiner recognizes that “Obviousness does not require absolute predictability, but at least some degree of predictability is required. Evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness. In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976)”. See MPEP 2143.02 (II). In the instant case, while Applicants seem to assert that this patient population is distinct, Applicants do not appear to provide any factual evidence to support their assertion.
Moreover, Applicants assert that the Examiners position that optimization of the dose and IV infusion timing would have been routine experimentation overlooks the claimed dose-timing regimen being tied to a particular bariatric high-BMI population. In particular, Applicants contend that there is no-prior art disclosure of the claimed dose-timing regimen in this specific patient subgroup, nor any teaching that small variations in infusion time or dose would materially impact PONV outcomes in high-BMI bariatric patients. Applicants again point to the specification as demonstrating that prophylactic amisulpride in the claimed dose and infusion regimen achieves complete response rate of 47.7% in BMI≥35, compared with 32.6% for placebo at 0-24 hrs (Table 2). Lastly, Applicants contend that unexpected results that are both statistically significant can demonstrate nonobviousness, particularly where the claimed invention solves a long felt need or addresses a specific problem not recognized in the prior art. Here, Applicants contend the prior art does not recognize that high-BMI bariatric patients present a distinct PONV challenge.
In response to this arguments, the Examiner would like to first point out that the instant claims recite a method of prophylactically treating post-operative nausea and/or vomiting in a patient in need thereof comprising intravenously administering to the patient 5 mg to 20 mg of amisulpride, wherein the patient has a BMI of equal to or greater than about 35. Thus, while the obviousness rejection concentrates of bariatric surgery, the claims do not specifically recite bariatric surgery. Secondly, the Examiner recognizes that study described in the specification encompassed a high BMI (≥30) patient population that is not solely limited to bariatric patients. For example, the specification teaches that the study was performed in adult patients (≥18 years) having a BMI≥30 who were undergoing elective ambulatory (day-case) or in patient surgery under general inhalational aneaestesia (page 16, lines 9-12). Thus, the results listed in Tables 1-8, which delineates results by BMI, appears to encompass a patient population that is not specifically limited to bariatric surgery. Regarding the bariatric surgery patients, only table 9 specifically singles them out, but does not delineate the results by BMI. Accordingly, Applicants arguments that the specification demonstrates that prophylactic amisulpride in the claimed dose and infusion regimen achieves complete response rate of 47.7% in BMI≥35, compared with 32.6% for placebo at 0-24 hrs is true for the “generalized” population, such arguments are not supported in the specification for specifically bariatric surgery patients. In view of the specification, it is noted that Applicants use of the phrase “high-BMI bariatric patients” should be understood to equate to BMI (≥30) and not limited to BMI (≥35). Moreover, as noted in the prior office action, similar to Gilbert, an improved complete response rate compared to placebo seems to be expected in both patient populations. "Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof." In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967) (see MPEP 716.02 (c). Regarding Applicants arguments pertaining to the optimization of the dose and IV infusion, the specification teaches a single dose of 5mg for prophylaxis given over about 2 minutes. Neither the specification or Applicants have provided any evidence of the criticality of the amount or the timing of the infusion. Regarding Applicants arguments pertaining to an long-felt need, it is noted that Applicants have not provided any evidence that a long-felt need was recognized, persistent and not solved by others (see MPEP 716.04).
As such, the arguments have not been found persuasive for the reasons set forth above and the rejection is maintained.
Claim(s) 1, 13-17, 19-21 and 25-27 remain rejected under 35 U.S.C. 103 as being unpatentable over Acacia Pharma Limited (WO2018/083466A1, 2018-11-05) referred to here as Acacia in view of Wolfe et al. (Circulation Research 2016; 118(11):1844-1855).
Acacia teaches a method of treating or preventing postoperative emesis in a patient, wherein the patient is undergoing a surgical procedure, comprising administering an effective amount of amisulpride to the patient (page 16, lines 3). With regards to the surgical procedure, the WO document teaches that surgical procedures include surgery of the GI tract, specifically bariatric surgery (page 14, lines 14-17 and lines 25-27). With regards to amisulpride, the WO document teaches that amisulpride is in the racemate form or is (S-)-amisulpride, wherein amisulpride is administered via an intravenous route such as infusion over about 1 to 2 minutes, as a single dose and administered at the time of induction of anesthesia (page 15, lines 14-26). Moreover, the WO document teaches that dose of amisulpride is 1 to 10 mg, 5 to 10 mg, or 5 mg (page 15, lines 29-34). The WO document further teaches that amisulpride is administered in combination with another anti-emetic, either separately, sequentially or simultaneously, wherein the other anti-emetic is a 5HT3 antagonist, an NK1 antagonist or a steroid (page 15, lines 1-5). Specifically, the WO document teaches that the anti-emetic is dexamethasone, odansetron, graisetron, palonosetron, aprepitant, netupitant or rolapitant (page 15, lines 6-8).
Acacia does not specifically teach that the patient undergoing bariatric surgery has a BMI of ≥35.
Wolfe et al. reviews the mechanisms underlying, and indications for, bariatric surgery in the reduction of cardiovascular disease (CVD), as well as other expected benefits of this intervention (Abstract). Wolfe teaches that specific criteria established by the National Institutes of Health consensus panel indicated that bariatric surgery is appropriate for all patients with body mass index (BMI) >40 and for patients with BMI 35 to 40 with associated comorbid conditions (page 1845, 1st column, lines 9-13).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by Acacia to include a patient undergoing bariatric surgery having a BMI of ≥35 in view of the teachings of Wolfe et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- Wolfe teaches that specific criteria established by the National Institutes of Health consensus panel indicated that bariatric surgery is appropriate for all patients with body mass index (BMI) >40 and for patients with BMI 35 to 40 with associated comorbid conditions.
In response to this rejection, Applicants arguments mirror those of the Gilbert-based rejections in attacking each of the references individually, assertions of the criticality the dosing and infusion timing and the recognition that bariatric patients with a BMI≥35 represent a distinct PONV risk category. These arguments have been fully addressed above and incorporated herein.
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Acacia Pharma Limited (WO2018/083466A1, 2018-11-05) referred to here as Acacia in view of Wolfe et al. (Circulation Research 2016; 118(11):1844-1855), as applied above to claims 1, 13-21 and 25-27, in further view of Habib (Anesthesiology 2019, 130:203-212).
Acacia teaches a method of treating or preventing postoperative emesis in a patient, wherein the patient is undergoing a surgical procedure, comprising administering an effective amount of amisulpride to the patient (page 16, lines 3). With regards to the surgical procedure, the WO document teaches that surgical procedures include surgery of the GI tract, specifically bariatric surgery (page 14, lines 14-17 and lines 25-27).
Acacia does not specifically teach that the patient has already administered a prophylaxis drug which is not amisulpride or a dopamine-2 antagonist. Moreover, the WO document does not teach that the said prophylaxis drug is anti-emetic selected from a 5HT3 antagonist, a corticosteroid, an anti-histamine, an anticholinergic, a H2 antagonist or a NK-1 antagonist. Nor does the WO document teach the patient is human.
Habib et al. teach a randomized, placebo-controlled Phase III trial of amisulpride for the rescue treatment of postoperative nausea or vomiting in patients failing prophylaxis (title). Habib et al. further teaches at present, prophylaxis most commonly involves 5HT3 agonist, such as ondansetron often in combination with dexamethasone, wherein consensus guidelines specifically recommend that an antiemetic used to treat postoperative nausea or vomiting should be from a different pharmacologic class to any drugs given prophylactically (page 203, 1st column, 2nd full paragraph and page 203, starting at 7th line). In line with the consensus guidelines, Habib et al. teach that patients had to have pre or perioperative nausea or vomiting prophylaxis, as long as no dopamine-antagonist antiemetics was included (page 204, 2nd column, 2nd full paragraph). With regards to the PONV prophylaxis, Habib et al. teach patients had received ondansetron, granisetron, dexamethasone, scopolamine or other agents (page 207, Table 1). Lastly, Habib et al. teaches that ten (10) milligrams of intravenous amisulpride, a dopamine antagonist, is superior to placebo at treating established postoperative nausea or vomiting after failed prophylaxis, whereas 5 mg was not superior to placebo (page 203, “What this article tells us that is new”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include a patient (human) that had received a non-dopamine antagonist as a prophylaxis in the method taught by Acacia. and Wolfe et al. in view of the teachings of Habib et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Habib et al. teaches that ten (10) milligrams of intravenous amisulpride, a dopamine antagonist, is superior to placebo at treating established postoperative nausea or vomiting after failed prophylaxis in humans.
In response to this rejection, Applicants contends that Habib reports a phase III trial of amisulpride 10 mg IV for rescue in patients who failed prior prophylaxis with 5HT3 agents or dexamethasone which was limited to rescue treatment of established PONV in a mixed surgical population. However, Applicants contend that Habib does not address prophylactic administration in bariatric surgery, BMI-based patient selection, or the claimed pattern of prophylaxis followed by amisulpride administration that yields Applicant’s outcomes. As such, Applicants contend that this three-way combination is based on hindsight using Applicant’s disclosure as a roadmap.
These arguments have been carefully considered, but are not found persuasive.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In the instant case, the level of ordinary skill at the time the invention was filed, in view of Habib, recognizes that amisulpride at 10mg IV is useful for rescue in patients who failed prior prophylaxis of established PONV. Regarding Applicants assertions of the claimed pattern of prophylaxis followed by amisulpride administration that yields Applicant’s outcomes, the Examiner has reviewed the specification and cannot find any support that prophylaxis followed by amisulpride administration yields Applicant’s outcomes. In contrast, the specification teaches prophylaxis OR rescue treatment, not the combination (see page 16, lines 14-15).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 13-17, 19-22 and 25-27 remain rejected on the ground of nonstatutory double patenting as being unpatentable over at least claim 1, 5-17, 25 of U.S. Patent No. US Patent No. 9,545,426B2 or at least claims 1-8 of US Patent No 11,357,753B2 to Gilbert et al. (2022-06-14) in view of Celio et al. (Obesity Surgery (2019) 29: 858-861, published online 2018-12-18).
US Patent No 9,545,462B2 claims a method for the prevention and/or treatment of post operative nausea and vomiting, wherein said method comprises administering amisulpride at a dose of 1 mg to 20 mg to a subject of a surgical procedure and in need of such prevention and/or treatment (claim 1). With regards to the surgical procedure, the US patent claims that the surgical procedure is chosen from procedures of the eye or ear, laparoscopic cholecystectomy, hysterectomy, breast surgery, abdominal surgery and gynecological surgery (claim 16), the racemate or (S-) amisulpride (claim 1 and claim 25), amisulpride is given at a dose of 2.5 mg, 5 mg or 20 mg and as a single dose (claims 12-14), the compound is administered via intravenous injection (claim 17), that the subject is human and further has received an anesthetic (claims 5 and 15), amisulpride is administered in combination with another anti-emetic drug, wherein the anti-emic drug is a 5HT3 antagonist such as ondansetron or dexamethasone (claims 7-10).
US Patent No. 11,357,753 claims a method of treating postoperative nausea and/or vomiting (PONV) in a patient, comprising administering amisulpride to the patient at a dose of 10 mg, where in the patient has been administered a prophylaxis drug for PONV prior to administration of amisulpride, and wherein the prophylaxis drug is not amisulpride (Claim 1). The US Patent further claims the prophylaxis drug is not a dopamine-2 antagonist (claim 2), the prophylaxis drug is an anti-emetic selection from a 5HT3 antagonist, a corticosteroid, an anti-histamine (H1), an anti-cholinergic, a H2 antagonist and a NK1 antagonist (Claim 3), the amisulpride is administered in combination with another anti-emetic, either sequentially or simultaneously (claim 4), the another anti-emetic is dexamethansone, ondansetron, ganisetron, palonsetron, aprepitant, netupitant or rolapitant (claim 6), amisulpride is a racemate (claim 7) and administered via intravenous route (Claim 8).
The US patents do not claim that the surgery is bariatric surgery, wherein the patient has a BMI of >=30 or >=35. Nor do the US patents claim that amisulpride is administered via IV infusion over from about 1 to about 2 minutes or a dose of about 10 mg.
Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV) and compares the incidence and severity of PONV between patients undergoing laparoscopic sleeve (SG) and gastric bypass (GB) (Abstract). Celio teaches that there was no significant difference in two populations, for example, BMI (46.9 +/- 6.1 vs. 50.5 +/- 10.1) (page 859, 2nd column, 1st full paragraph). In conclusion, Celio et al. teach that PONV is particularly important in bariatric patients as it is a major contributor towards readmission and dehydration with no significant difference in PONV between the two most commonly performed weight loss procedures (page 861, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include a patient undergoing bariatric surgery in the method claimed by each of the US Patents in view of the teachings of Celio et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-The US Patents claim that amisulpride is useful at preventing and/or treating post operative nausea and vomiting during a surgical procedure, and
- Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV).
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include optimize the amount and administration timing in the method claimed by each of the US Patents.. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
Generally, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In response to these rejection, Applicants wishes to hold these rejections in abeyance pending the resolution of the rejections addressed above. As such, the rejection is maintained.
Claims 1, 13-17, 20-22 and 25-27 remain rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 9 and 11-12 of U.S. Patent No. 10,322,106B2 to Gilbert et al. (2019-06-18) in view of Gilbert et al. (US Patent No. 9,545,426B2, 2017-01-17) in view of Celio et al. (Obesity Surgery (2019) 29: 858-861, published online 2018-12-18).
US Patent No 10,322,106B2 claims a method of treatment or prevention of chemotherapy or radiotherapy induced nausea and/or vomiting the method comprising administering at least one unit dose of an acute-phase anti-emetic to a patient in need thereof, wherein the patient is receiving or has received a chemotherapy or radiotherapy; and administering an effective amount of at least one non-IV injectable unit dose of amisulpride as a delayed phase anti-emetic to the patient (claim 9 of the US Patent). The US Patent further claims that the patient is administered at least one unit dose of another-delayed phase anti-emetic on the same day as the dose of amisulpride wherein the another delayed phase anti-emetic agent is a 5FT3 antagonist, and NK1 antagonist or a steroid (claim 12).
The US Patent does not specifically claim that the method treats or prevents post operative nausea or vomiting in a subject of a surgical procedure, nor the dosages of amisulpride, routes of administration of the specific 5FT3 antagonist, and NK1 antagonist or a steroid.
Gilbert et al. teach a method for the prevention and/or treatment of post operative nausea and vomiting, wherein said method comprises administering amisulpride at a dose of 1 mg to 20 mg to a subject of a surgical procedure and in need of such prevention and/or treatment (claim 1 of Gilbert). With regards to the surgical procedure, the US patent teaches that the surgical procedure is chosen from procedures of the eye or ear, laparoscopic cholecystectomy, hysterectomy, breast surgery, abdominal surgery and gynecological surgery (claim 16 of Gilbert). Moreover, Gilbert teaches that amisulpride may be particularly useful in therapy patients receiving cancer chemotherapy or radiotherapy (column 2, lines 44-50). With regards to amisulpride, the US patent teaches that substantially pure enantiomer or non-racemic mixtures may be used, but it may be preferred to use the racemate or (S-) amisulpride (column 3, lines 4-7 and claim 25 of Gilbert). With regards to the dose of amisulpride, the US Patent teaches that amisulpride is given at a dose of 2.5 mg, 5 mg or 20 mg and as a single dose (claims 12-14 of Gilbert, column 7, lines 50-52). With regards to the routes of administration, the US patent teaches that the compound is administered via intravenous injection, intramuscular injection, subcutaneous injection, orally or topically (claim 17-51 of Gilbert). With regards to the subject, the US Patent teaches that subject is human and further has received an anesthetic (claims 5 and 15 of Gilbert). Moreover, the US Patents teaches that amisulpride is administered in combination with another anti-emetic drug, wherein the anti-emic drug is a 5HT3 antagonist such as ondansetron or dexamethasone claims 7-10 of Gilbert and column 4, lines 60-67).
Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV) and compares the incidence and severity of PONV between patients undergoing laparoscopic sleeve (SG) and gastric bypass (GB) (Abstract). Celio teaches that there was no significant difference in two populations, for example, BMI (46.9 +/- 6.1 vs. 50.5 +/- 10.1) (page 859, 2nd column, 1st full paragraph). In conclusion, Celio et al. teach that PONV is particularly important in bariatric patients as it is a major contributor towards readmission and dehydration with no significant difference in PONV between the two most commonly performed weight loss procedures (page 861, 2nd column, 1st full paragraph).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include a patient undergoing bariatric surgery in the method claimed in the US Patent in view of the teachings of Celio et al. and adjust the doses in view of the teachings of Gilbert et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
- Gilbert et al. teach that amisulpride is useful at preventing and/or treating post operative nausea and vomiting during a surgical procedure, and
- Celio et al. teach the common reason for readmission after bariatric surgery is postoperative nausea and vomiting (PONV).
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to include optimize the amount and administration in the method by the US Patent in view of Gilbert.. One of ordinary skill in the art would have been motivated to make such an optimization, with a reasonable expectation of success, because:
- Gilbert et al. teach that amisulpride is useful at preventing and/or treating post operative nausea and vomiting during a surgical procedure in a dosage ranging from 1 mg to 20 mg, and
-The route of administration may depend on the condition being treated, for example, amisulpride can be formulated with morphine in an infusion bag (column 5, lines 5-13).
Generally, 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
In response to these rejection, Applicants wishes to hold these rejections in abeyance pending the resolution of the rejections addressed above. As such, the rejection is maintained.
Conclusion
Therefore, No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626
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