DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions. 1
Status of Claims
Claims 18-34 are pending.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 7, 2025, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 18-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for an embodiment of the invention where 10 mg of metoclopramide is administered enough times a day for total daily dose of 60 mg intranasally, does not reasonably provide enablement for the full scope of about 5-10 mg administered 1-4 times daily, as exemplified by claims 18 and 20.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
Applicant’s attention is drawn to In re Wands, 8 USPQ2d 1400 (CAFC1988) at 1404 where the court set eight forth factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: (1) the nature of the invention; (2) the state of the prior art; (3) the relative skill of those in the art; (4) the predictability or unpredictability of the art; (5) the breadth of the claims; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
The predictability or unpredictability of the art: The instant claimed invention is highly unpredictable since a person having ordinary skill in the art (PHOSITA) recognizes the unpredictability with the treatment of gastroparesis with nasally administered metoclopramide. There is only one specific dose regimen that is FDA approved to treat gastroparesis intranasally with metoclopramide.
Per GIMOTI™ JAMA Medical Letter,2 the FDA approved GIMOTI™, a metoclopramide nasal spray to treat gastroparesis, where 15 mg was administered four times day (for a total daily dose of 60 mg). See Table 2. See also Section 10 of Kalas et al. 3 The FDA approved therapy of gastroparesis with nasally administered metoclopramide requires a minimum 60 mg daily dose. There is no FDA approved therapy for treatment of gastroparesis with intranasal metoclopramide dosed under 60 mg/day.
Accordingly, the unpredictability in the art is Wands factor against enablement of the claims.
The breadth of the claims : Claims 18-20 are directed to a method of treating gastroparesis in a subject (human) by intranasally administering a metoclopramide spray from about 5 to about 10 mg (concentration 10 millimolar), from 1 to 4 times a day (total dose 60 mg). Claims 21- disclose benzalkonium chloride and various buffers and excipients (sodium citrate, EDTA and sorbitol, substantially free of any additional antioxidant); a w/v concentration to about 0.005% to about 0.05%; above pH 4.5; claimed osmolarity.
The instant claims are deemed broad since these they allow for metoclopramide doses under the FDA approved daily dose of 60 mg. The scope of claims is a Wands factors weighing against the full scope of enablement of the claims.
The amount of direction or guidance presented, and the presence or absence of working examples: It has been established that “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art.” In re Fisher, 427 F.2d 833, 839 166 USPQ 18, 24 (CCPA 1970).
There is no working example, other than the prophetic Example 4 starting at paragraph 94 (Clinical Study of Nasally Administrable Metoclopramide Composition) which provides enablement of total daily doses of 60 mg metoclopramide (i.e. 15 mg administered intranasally four times a day).
In summary, per the Wands factors detailed above, the claims are not enabled for the full scope as claimed.
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 18-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 6, 10, 13, 16, 21, 24, 27-29, 33, 36-37, 40, 44, 54-55, and 58-59 of copending Application No. 19238026 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims and reference claims are both directed to administering a nasally administered metoclopramide to a patient in need such as where the patient has diabetic gastroparesis, and the formulation has overlapping concentrations and excipients and is given in overlapping doses.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference application teaching the administration of a similar composition to the same patient population suffering from gastroparesis.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of US Patent 8334281 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-34 are discussed above and their teachings are incorporated herein.
The reference patent generally claims a pharmaceutical composition comprising metoclopramide, or a pharmaceutically-acceptable salt thereof, a citrate buffer, and benzalkonium chloride; wherein the composition is a nasal solution that is clear to pale yellow when compared to standard E, 32 USP <631> on storage at a temperature of 40.degree. C. for at least about 4 weeks; and wherein the composition has a citrate concentration ([citrate]=[citric acid]+[dihydrogen citrate ion]+[hydrogen citrate ion]+[citrate ion]) of at least about 10 millimolar, and so forth, with overlapping scope.
Regarding the limitation of a citrate and/or acetate buffer, the reference ‘281 patent discloses a citrate buffer as claimed. Regarding the method of treating gastroparesis in a patient via intranasal administration of metoclopramide the reference ‘281 patent discloses method of treating a patient, comprising intranasally administering to the patient an effective amount of a composition as claimed; where the patient’s disorder is treatable with metoclopramide, such as gastroparesis, see claims 14-16 and 27-29. While the ‘281 patent does not necessarily recite the limitation of about 5 to about 10 mg of metoclopramide, it does teach a concentration of about 20 to about 30% w/v concentration, allowing for the adjustment of metoclopramide to arrive at the claimed dose range of about 5-10 mg, see claim 6 .
Regarding the limitation of administration of intranasal spray, 1-4 times a day, the reference ‘281 patent discloses intranasal administration of the metoclopramide to treat gastroparesis, where it would be obvious to administer such metoclopramide intranasally to treat gastroparesis at least once on any given day, see claims 14-16 and 27-29.
Regarding the limitation of benzalkonium chloride limitation, the reference ‘281 patent discloses benzalkonium chloride in claims 1, 10 and 17.
Regarding the limitation of benzalkonium chloride from about 0.005% (w/v) to about 0.05% (w/v), the ‘281 patent discloses a concentration of benzalkonium chloride from about 0.005% (w/v) to about 0.05% (w/v), see claims 7 and 25.
Regarding the limitation of a pH of above about 4.5, the ‘281 patent discloses having a starting pH of at least about 4.5, see claim 20.
Regarding the limitation of metoclopramide composition has an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg, the ‘281 patent discloses an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg. See claim 26.
Regarding the limitation of the list of buffers recited therein and claim 11 noting sodium citrate buffer, the ‘281 patent discloses a near similar list of buffers, including citrate and acetate, see claim 13. See also claim 1.
Regarding the limitations of symptoms treated with metoclopramide , such as emesis, delayed emesis and nausea, as noted above, as per the ‘281 patent, claims 14-16 and 27-29 recites these limitations, as noted above.
Regarding the limitation of sorbitol and EDTA, the ‘281 patent discloses sorbitol and EDTA, see claim 23.
Regarding the limitation of treating a human, it would be obvious to treat a human as per the ‘281 patent noting intranasal administration of metoclopramide to treat gastroparesis, as notice is given humans suffer from gastroparesis, emesis, nausea etc., see claims 14-16 and 27-29.
Regarding claim the limitation of wherein the composition is substantially free of any additional antioxidant, the ‘281 patent discloses wherein the composition is substantially free of any additional antioxidant, see claim 4.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11020361. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-34 are discussed above and their teachings are incorporated herein.
Regarding claims 18-34, claim 1 of the ‘361 patent discloses a near identical method of treating gastroparesis as claimed by Applicant, but differs as it is limited to the citrate salt, whereas the claimed method is directed to citrate or acetate.
While the ‘361 patent does not necessarily recite the limitation of about 5 to about 10 mg of metoclopramide, it does teach that its dose is 15 mg (see claim 1), where it is administered twice a day (see claim16). As a total dose per day is a claimed goal (1-4 times a day per claim 3, where total dose of 1 to 4 times a day at 5 or 10 mg, results in a range of 5 mg to 40 mg a day, the ‘361 patent teaches a total dose of 30 mg (15 mg twice a day) that falls within a total dose claimed by the examined claims.
Regarding the claimed intranasal spray, 1-4 times a day, claim 1 of the reference patent discloses intranasal administration and claim 16 discloses the intranasal spray is administered twice.
Regarding the claimed benzalkonium chloride limitation, this limitation is disclosed in claim 3 of the reference patent.
Regarding the limitation of benzalkonium chloride from about 0.005% (w/v) to about 0.05% (w/v), this limitation is disclosed in claim 4 of the reference patent.
Regarding the limitation of a pH of above about 4.5, this limitation is disclosed in claim 5 of the reference patent.
Regarding the limitation of where the metoclopramide composition has an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg, this limitation is disclosed in claim 7 of the reference patent.
Regarding the limitation of list of buffers recited therein (sodium citrate buffer), these limitations are disclosed in claims 8 and 10 of the reference patent.
Regarding the limitations of symptoms treated with metoclopramide, such as emesis, delayed emesis and nausea, as noted above, these limitations are disclosed in claims 1, 11 and 12 of the reference patent.
Regarding the limitation of sorbitol and EDTA, this limitation is disclosed in claim 14 of the reference patent.
Regarding the limitation of treating a human, this limitation is disclosed in claim 17 of the reference patent.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11628150. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-34 are discussed above and their teachings are incorporated herein.
Regarding claims 18-34 and the claimed composition and method of treating gastroparesis in a patient via intranasal administration of metoclopramide, the ‘150 patent discloses a pharmaceutical composition formulated for intranasal administration, the pharmaceutical composition: comprising metoclopramide, or a pharmaceutically-acceptable salt thereof; having a pH of above about 4.5; providing less than about 2% average change in percent optical density (O.D.) per week per 200 mg/mL of metoclopramide when stored at a temperature of 40° C. and 75% relative humidity; and comprising a citric acid buffer comprising a combination of citric acid monohydrate and sodium citrate dihydrate, wherein the combination provides a citrate concentration of at least 10 millimolar, and wherein the citric acid monohydrate is at a concentration of up to 50 millimolar.
Regarding the limitation of treating a patient in need for gastroparesis, the reference patent discloses intranasal administration of metoclopramide to a patient of a disorder treatable with metoclopramide, where the patient is human and the disorder is selected from gastroparesis, emesis, delayed emesis, and nausea. See claim 11.
While the ‘150 patent does not necessarily recite the limitation of about 5 to about 10 mg of metoclopramide, it does teach that its concentration of metoclopramide is at a concentration of 200 mg/ml, where it would be obvious to arrive at such a 5-10 mg dose based on the concentrations claimed. See claim 1.
Regarding the limitation of the administration of intranasal spray, 1-4 times a day, the reference patent discloses the intranasal spray is administered as two sprays, see claim 13, where it would be obvious to administered two sprays to a patient in a day to treat the claimed subject.
Regarding the benzalkonium chloride limitation, this limitation is disclosed in claim 2 of the reference patent.
Regarding the limitation of benzalkonium chloride from about 0.005% (w/v) to about 0.05% (w/v), this limitation is disclosed in the reference patent at claim 16.
Regarding the limitation of a pH of above about 4.5, this limitation is disclosed in claim 17 of the reference patent.
Regarding wherein the metoclopramide composition has an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg, this limitation is disclosed in claim 20 of the reference patent.
Regarding the list of buffers recited therein and claim 11 noting sodium citrate buffer, this limitation is disclosed in claim 6 (among others) of the reference patent.
Regarding the limitations of symptoms treated with metoclopramide, such as emesis, delayed emesis and nausea, as noted above, these limitations are disclosed in claim 11 of the reference patent.
Regarding claim 15 and the limitation of sorbitol and EDTA, this limitation is disclosed in claim 23 of the reference patent.
Regarding the limitation of treating a human, it would be obvious to treat a human as per the ‘150 patent noting intranasal administration of metoclopramide to treat gastroparesis, as notice is given that humans suffer from gastroparesis, emesis, nausea etc., see claim 11.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claim(s) 1-20 of U.S. Patent No. 11813231 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-34 are discussed above and their teachings are incorporated herein.
Regarding claims 18-34, the reference patent discloses an intranasal pharmaceutical composition having a pH of above about 4.5, comprising metoclopramide, or a pharmaceutically acceptable salt thereof, and either (1) benzalkonium chloride at a concentration of at least 0.025% (w/v) and up to about 0.05% (w/v) or (2) benzyl alcohol at a concentration of less than 1% (w/v); wherein the intranasal pharmaceutical composition exhibits less than about 2% average change in percent optical density (O.D.) per week per 200 mg/mL of metoclopramide when stored at a temperature of 40° C. and 75% relative humidity for at least about 4 weeks, see claim 1. The reference patent discloses a method of treating a patient, comprising intranasally administering to the patient an effective amount of the intranasal pharmaceutical composition of claim 1; wherein the patient has a disorder that is treatable with metoclopramide; wherein the disorder that is treatable with metoclopramide is selected from the group consisting of gastroparesis, emesis, delayed emesis, and nausea; wherein the patient is human. See claims 10-13.
While the ‘231 patent does not necessarily recite the limitation of 5 to 10 mg of metoclopramide, it does teach that its concentration of metoclopramide is from about 20.0% w/v to about 30% w/v, see claim 4, where it would be obvious to arrive at such a about 5-10 mg dose range based on the w/v % concentrations claimed. See also claim 1 noting a concentration of 200 mg/ml.
Regarding the limitations of administration of intranasal spray, 1-4 times a day, the ‘231 patent discloses intranasal administration of the metoclopramide to treat gastroparesis, where it would be obvious to administer such metoclopramide intranasally to treat gastroparesis at least once on any given day. See claims 10-13.
Regarding the limitation of a benzalkonium chloride limitation, this limitation is disclosed in claim 1 of the reference patent, ‘231 patent.
Regarding the limitation of benzalkonium chloride from about 0.005% (w/v) to about 0.05% (w/v), an overlapping range is disclosed in claim 1 of the reference patent, ‘231 patent, “(1) benzalkonium chloride at a concentration of at least 0.025% (w/v) and up to about 0.05% (w/v).”
Regarding the limitation of a pH of above about 4.5, this limitation is disclosed in the reference patent at claim 1.
Regarding the limitation of where the metoclopramide composition has an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg, this limitation is disclosed in the reference patent at claim 5.
Regarding the limitation of a list of buffers recited therein and claim 11 noting sodium citrate buffer, this limitation is disclosed in claim 8 of the reference patent.
Regarding the limitations of symptoms treated with metoclopramide, such as emesis, delayed emesis and nausea, as noted above, these limitations are disclosed in the reference patent at claims 10-13.
Regarding the limitation of sorbitol and EDTA, the reference patent discloses sorbitol and EDTA, see claim 3.
Regarding the limitation of treating a human, the limitation of a human is disclosed in claim 13.
Regarding the limitation of wherein the composition is substantially free of any additional antioxidant, this limitation is disclosed in claim 2.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of US 12194008. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-34 are discussed above and their teachings are incorporated herein.
Regarding claims 18-34, the reference application discloses a method of treating gastroparesis in a patient, comprising intranasally administering to the patient an amount of a metoclopramide composition effective to deliver a daily dose of about 30 mg of metoclopramide, or a pharmaceutically-acceptable salt thereof, wherein the metoclopramide composition comprises citrate in a concentration of at least about
10 millimolar, and wherein the intranasally administering is effective to treat gastroparesis. See claim 1. While the claimed dose comprises the dose range of about 5-10 mg, the open comprising term allows that more than one dose a day can be administered, i.e. 3 times a day at 10 mg, with a total dose of 30 mg as claimed. The reference patent discloses a daily dose of 30 mg. See claim 1.
Regarding examined 18-34, the reference patent discloses an intranasal spray; administration of the spray 1-4 times a day; benzalkonium chloride in a concentration from about 0.005% (w/v) to about 0.05% (w/v); a pH of above 4.5; an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg; the recited listed of buffers disclosed therein (identical to those taught by the reference patent, such as sodium citrate); a symptom treatable of metoclopramide; the composition further comprising EDTA and sorbitol, while being free of any additional antioxidant. See claims 2-16.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Claims 18-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US 12194008.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-34 are discussed above and their teachings are incorporated herein.
Regarding claims 18-34, the reference patent discloses a method of treating gastroparesis in a patient, comprising intranasally administering to the patient an amount of a metoclopramide composition effective to deliver a daily dose of about 30 mg to about 60 mg of metoclopramide, or a pharmaceutically-acceptable salt thereof,
wherein the metoclopramide composition comprises citrate in a concentration of at least about 10 millimolar, and
wherein the intranasally administering is effective to treat gastroparesis. See claim 1.
While the claimed dose comprises the dose range of about 5-10 mg, the open comprising term allows that more than one dose a day can be administered. A claimed total dose would 10 mg administered 3 times a day, i.e., 30 mg. The reference patent discloses a daily dose of 30 mg. See claim 1
Regarding examined 18-34, the reference patent discloses an intranasal spray; administration of the spray 1-4 times a day; benzalkonium chloride in a concentration from about 0.005% (w/v) to about 0.05% (w/v); a pH of above 4.5; an osmolality of from about 500 mOsm/kg to about 1400 mOsm/kg; the recited listed of buffers disclosed therein (identical to those taught by the reference patent, such as sodium citrate); a symptom treatable of metoclopramide; the composition further comprising EDTA and sorbitol, while being free of any additional antioxidant. See claims 1-15.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Claims 18-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of US 12377064
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following.
Examined claims 18-20 are discussed above and their teachings are incorporated herein.
Regarding claims 18-20, the reference application at claim 1 discloses a method for treating symptoms associated with moderate to severe gastroparesis, the method comprising:
intranasally administering to a patient having moderate to severe gastroparesis, a dose of 5 mg to 20 mg of intranasal metoclopramide, or a pharmaceutically acceptable salt thereof, 1 to 4 times per day, for a period of 1 to 12 weeks, wherein a patient having moderate to severe gastroparesis as defined therein.
A person having ordinary skill in the art (PHOSITA) following the teachings of the reference patent teaching the administration of a similar composition to the same patient population suffering from gastroparesis would have found prima facie obvious to arrive at the claimed method.
Conclusion and Correspondence
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM LEE whose telephone number is (571)270-3876. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM Y LEE/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
1 CONTINUING DATA
This application is a CON of 17/366,839 07/02/2021 PAT 12194009
17/366,839 is a CON of 17/100,664 11/20/2020 PAT 11628150
17/100,664 is a CON of 16/181,841 11/06/2018 PAT 11020361
16/181,841 is a CON of 15/130,086 04/15/2016 ABN
15/130,086 is a CON of 13/660,709 10/25/2012 ABN
13/660,709 is a CON of 12/645,108 12/22/2009 PAT 8334281
12/645,108 has PRO 61/140,034 12/22/2008
2 See Editors: Abramowicz et al. Metoclopramide Nasal Spray (Gimoti) for Diabetic Gastroparesis, JAMA The Medical Letter on Drugs and Therapeutics. January 11, 2021;63(1615):5-7.
Published Online: July 20, 2021
2021;326;(3):270-271. doi:10.1001/jama.2020.26625
3 Kalas et al. Current and emerging pharmacotherapy for the treatment of gastroparesis EXPERT OPINION ON PHARMACOTHERAPY 2024, VOL. 25, NO. 5, 541–549
https://doi.org/10.1080/14656566.2024.2344646
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