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 .
DETAILED ACTION
A request for continued examination under 37 C.F.R. 1.114, including the fee set forth in 37 C.F.R. 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 C.F.R. 1.114, and the fee set forth in 37 C.F.R. 1.17(e) has been timely paid, the finality of the previous Office Action has been withdrawn pursuant to 37 C.F.R. 1.114. Applicant’s submission filed Sep. 12, 2025 has been received and entered into the present application.
Status of claims
The amendment filed on Oct. 10, 2025 is acknowledged. Claims 2-16, 19-21, and 23-34 have been canceled. New claims 35-50 have been added. Claims 1, 17-18, 22, and 35-50 are under examination in the instant office action.
Applicants' arguments and declaration, filed on Sep. 10, 2025 and Oct. 10, 2025, have been fully considered but they are not found to be persuasive or moot in view of a new ground of rejection. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied in view of the amendments. They constitute the complete set presently being applied to the instant application.
In view of the abandonment of 17/823301, the non-statutory ODP rejection is hereby withdrawn.
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 of this title, 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.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1, 17-18, 22, and 35-50 are rejected under 35 U.S.C. 103 as being unpatentable over US 6248789 (hereafter, Weg) and WO 2019126108 in view of Granata (Schmerz, 30:286-288, 2016, cited in the IDS filed on 8/30/2022) in further view of Singh et al. (Pharmacotherapy, 38 (3):390–401, 2018).
Weg teaches a method for treating pain in a subject comprising administering transmucosally, preferably nasally, a dose of ketamine effective to alleviate pain to a subject suffering from pain (abstract, col 2, lines 58-61 and col, 3, lines 36-38). Weg further teaches that transmucosal administration of ketamine is rapid, allowing for fast action of the drug and avoids side effects associated with a bolus dose of ketamine delivered i.v. or i.m. administration; and a small transmucosal or transdermal dose of ketamine can be administered more frequently, which achieves a virtual steady state level of the drug that can be modulated as needed by the subject (col 3, lines 9-25). Weg further teaches that it provides for outpatient treatment of episodic and breakthrough pain conditions, which are not amenable to treatment with i.v. or i.m. bolus administration of the drug because of the need for medical intervention for these procedures (col 3, lines 26-30). Weg further teaches that transmucosal administration of ketamine can relieve or alleviate episodes of acute breakthrough pain that can occur in a chronic pain condition (col 5, lines 23-26).
Weg discloses nasal spray comprising 100 mg/ml ketamine solution (col 11, lines 44-50). The solution implies that ketamine is in a dissolved state and the concentration of ketamine falls within the claimed range. Weg further discloses that administration of an analgesic dose of ketamine advantageously allows for patient self- administration of the drug, which provides for pain management on an outpatient basis (column 3, lines 4-7). Weg further discloses that the nasal spray bottle was prepared in order to provide sustainable pain medication on an outpatient basis (col. 11, lines 47-51). As to the recitation: “ketamine is administered as the only pharmaceutical ingredient for the treatment of cluster headache”, Weg teaches administration of ketamine, either alone or in combination with other pain medications, to manage and treat pain (abstract). Thus, Weg does teach and suggest administering ketamine alone as the only therapeutically active ingredient for treating pain.
Also, Weg teaches that ketamine can surprisingly be administered nasally to alleviate pain safely and effectively (col 2, lines 47-52) and nasal administration of ketamine is effective for treating migraine headache pain (col 4, lines 35-37). Weg further teaches that the pain-alleviating dose of ketamine is approximately 0.01 to approximately 1 mg/kg of body weight and the total dose of ketamine per nasal administration ranges from about 1 to about 30 mg (col 4, lines 23-28). Weg further discloses a patient suffering from intractable bladder pain, and taking a variety of narcotics, analgesics, and sedatives in an unsuccessful attempt to control the pain, was able to achieve more satisfactory pain management by nasal administration of 16-32 mg of ketamine (col. 5, line 62-col. 6, line 2).
In addition, Weg specifically discloses a 5 ml bottle containing 100 mg/ml ketamine solution was prepared and a single spray (one dose) from the bottle delivered approximately 1/6 ml of solution, i.e., 16 mg of ketamine (col. 11, lines 44-47). Weg further discloses that the patient was instructed to self-administer 1-2 sprays from the bottle for severe pain (col. 11, lines 47-51). Furthermore, Weg discloses that the patient has demonstrated remarkable pain management with nasal administration of ketamine and nasal ketamine has been particularly effective for control of breakthrough pain (col 11, line 52-col 12, line 3). Furthermore, it discloses that subjects suffering from intractable pain, severe migraine headaches, chronic fatigue syndrome, and other painful afflictions, have successfully employed nasal administration of ketamine to treat these problems (col 12, lines 4-8).
As to claims 46-47, Weg teaches that transmucosal administration of ketamine allows for effective pharmacokinetics with low doses of the drug, thus avoiding dysphoria or other side effects associated with bolus i.v. or i.m. dosing.
WO 2019126108 discloses aqueous solution for intranasal delivery comprising 161.4 mg/mL of esketamine (S-ketamine) hydrochloride (equivalent to 140 mg/mL of esketamine base), 0.12 mg/mL of ethylenediaminetetraacetic acid (EDTA) and 1.5 mg/mL citric acid, at a pH of 4.5 in water (p20, lines 1-9). WO 2019126108 discloses the esketamine is delivered intranasally using a nasal spray pump, wherein the pump delivers 16.14 mg esketamine hydrochloride (14 mg esketamine base) per 100 µl spray (p20, lines 9-13). WO 2019126108 also discloses that the nasal spray device is a single-use device (one-dose container), which is configured to administer the esketamine in two or more sprays and from about 28 to about 84 mg of esketamine (p48, lines 8-9 and claims 15 and 18-21). WO 2019126108 teach that the device may take the form of a double-stroke disposable pump, which is disposed of after a single use and enables individual partial discharges with high dosing precision and reliability (p48, lines 5-7). In addition, WO 2019126108 teaches that with respect to dosage amounts, one device may be used for a 28 mg dose, two devices for a 56 mg dose, or three devices for an 84 mg dose and it is also preferable to have a 5-minute interval between the use of each device (p48, lines 10-15). WO 2019126108 further teach that the total daily dosage may be administered in divided doses of two, three or four times daily, divided doses are administered about within 20 minutes, about 15 minutes, about 10 minutes, about 5 minutes, about 4 minutes, about 3 minutes, about 2 minutes, about 1 minute, or less of each other (p45, lines 15-20).
Weg or WO 2019126108 does not specifically teach the use of ketamine for treating chronic cluster headache as amended.
Granata discloses that the impact of cluster headache attacks on the individual patients can results in tremendous pain and disability (abstract). Granata further discloses the use of intravenous ketamine for treating cluster headaches including chronic cluster and episodic form (abstract). Also, Granata discloses that the ketamine was intravenously administered in a dose of 0.5 mg/kg (abstract). In addition, Granata discloses that the attacks are completely aborted in 100% of patients with episodic headaches and in 54% of patients with chronic cluster headaches for a period of 3-18 months (abstract).
Singh et al. disclose intranasal ketamine and its potential role in cancer-related pain (abstract) and teach that intranasal administration has been proposed as a promising delivery route for ketamine and other agents because it allows for outpatient maintenance dosing, is a needle-free option, and has greater bioavailability compared to the oral route due to the absence of a hepatic first-pass (p394, col 2, para 4). Also, Singh et al. disclose that the bioavailability of intranasal ketamine in a nasal spray is approximately 45 % (p393, col. 1 para 1). In addition, Singh et al. disclose various clinical studies regarding treatment of pain conditions with intranasal ketamine wherein one of the studies discloses intranasally administering 10-50 mg of ketamine in a volume of 0.1 ml (100 µl) in a nasal spray and repeating dosing up to maximum total 0.5 ml (five doses) for treating breakthrough pain episodes (p396, Table 3).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the aqueous solution in the form of a nasal spray comprising ketamine such as racemic mixture or S-ketamine taught by Weg and WO 2019126108 for treating a headache condition such as chronic cluster headache because of the following reasons. First, intravenous ketamine was already taught to be effective for treating cluster headaches including chronic cluster headache as evidenced by Granata. Also, Weg teaches that nasal administration of ketamine is particularly effective for treating episodic and breakthrough pain conditions and migraine headache with additional advantages over i.v. or i.m. administration as stated above. Thus, one of ordinary skill in the art would have been motivated to use the ketamine aqueous solution in a nasal spray taught by Weg and WO 2019126108 in the treatment of chronic cluster headache, especially for those patients who have onset of a cluster headache episode and thus need fast action of the drug while avoiding side effects associated with a bolus dose of ketamine and for improving patient’s convenience since intranasal administration does not need medical intervention and can be self-administered by the patient on needed-basis as evidenced by Weg. In addition, Singh et al. teaches that intranasal administration is a promising delivery route for ketamine and may offer practical alternatives to intravenous ketamine when treating pain conditions. The skilled artisan would have reasonably expected that the intranasal ketamine of Weg and WO 2019126108 would be effective for treating chronic cluster headache similarly to intravenous ketamine.
As to the one-dose container (single use container), it was known to use intranasal ketamine in a single use device which is configured to administer the esketamine in two or more sprays and from about 28 to about 84 mg of esketamine as evidenced by WO2019126108. Thus, one of ordinary skill in the art would have been motivated to use such available single use device containing a single spray amount for further improving dosing precision in administering the intranasal ketamine formulation because the device would make it easier to deliver the ketamine nasal formulation with high dosing precision and reliability for self-administration by patients as evidenced by WO2019126108.
As to the total dosage (total doses of 45 mg to 75 mg), the amount in each dose, the number of divided doses and the interval between the doses recited in new claims 37-39, WO 2019126108 discloses the total daily dosage, the amount in each dose (14-16 mg per 100 µl spray), the number of divided doses and the interval between the doses, which overlap or very closer to those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP 2144.05 Obviousness of Ranges.
Also, WO 2019126108 discloses that the nasal spray device is a single-use device (one-dose container), which is configured to administer the esketamine in two or more sprays and from about 28 to about 84 mg of esketamine, which overlaps those clamed. Weg specifically discloses administering a single spray (one dose) from the bottle (100 mg/ml ketamine solution) containing 16 mg of ketamine and the patient was instructed to self-administer 1-2 sprays from the bottle for severe pain. Weg further teaches that the effective dose is titrated under the supervision of a physician or medical care provider, so that the optimum dose for the particular application is accurately determined and once the dosage range is established, a further advantage of the invention is that the patient can administer ketamine on an as-needed, dose-to-effect basis (col 6, lines 40-50). In addition, it was known in the art that the bioavailability of the nasal spray is approximately 45% as evidenced by Singh et al. Based on the bioavailability of nasal ketamine compared to intravenous ketamine, a person skilled in the art would have been motivated to adjust the total dosage amount of nasal ketamine to attain plasma concentration equivalent or closer to intravenous administration. Since Granata discloses that the ketamine was intravenously administered in a dose of 0.5 mg/kg (e.g., 32.5 mg for 65 kg) in the treatment of cluster headache, one of ordinary skill in the art would have reasoned that about 72 mg (32.5/0.45) of nasal ketamine would provide plasma concentration comparable to 0.5 mg/kg of intravenous based on 45 % bioavailability of nasal ketamine. Based on the ketamine dose disclosed in Weg and WO 2019126108 modified by Granata and Singh et al., a person of ordinary skill in the art would be capable of optimizing an intranasal dose of ketamine per administration and administration frequency for reaching a concentration effective for treating a chronic cluster headache similar to intravenous administration without undue experimentation.
As to claim17, it was well known in the art that ketamine was used in form of hydrochloride salt as evidenced by Singh et al (p395, col., 2, para 2) and WO 2019126108. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the racemic ketamine in hydrochloride salt on the reasonable expectation of success.
As to claim 22, which recites intended results, the prior art teaches and suggests intranasally administering the same aqueous composition comprising ketamine in overlapping amount, thus it necessarily results in a systemic absorbed dose essentially corresponding to or lower than the absorbed dose resulting from intravenous (IV) administration, whereby undesirable side effects of ketamine when used in the treatment of cluster headache are reduced or eliminated as claimed. This is further evidenced by Weg, which teaches transmucosal administration of ketamine avoids dysphoria or other side effects associated with bolus i.v. or i.m. dosing. It is noted that products of identical chemical composition cannot have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). When the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Alternately, the discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
As to new claim 45, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the aqueous solution in the form of a nasal spray comprising ketamine where other treatment regimens have failed because the skilled artisan, who is a medical practitioner in this case, would seek alternative treatment when other therapy was not working and would have been motivated to use ketamine which is taught to be effective for treating chronic cluster headache. That’s what the skilled artisan would generally do.
As to new claims 43-44 and 48-49, Weg teaches that a small transmucosal or transdermal dose of ketamine can be administered more frequently for achieving a virtual steady state level of the drug that can be modulated as needed by the subject. Weg also teaches that the patient can administer ketamine on an as-needed, dose-to-effect basis and thus, the frequency of administration is under control of the patient (col 6, lines 41-50). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer repeated doses until desired treatment effect is obtained. Also, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to continue the treatment until desired pain relief is obtained based on well-known pain intensity measurement such as ten-point numeric rating scale (NRS). That’s what the skilled artisan who may be a medical practitioner in this case would generally do.
Response to Applicant’s argument
Responses are limited to Applicants' arguments relevant to either reiterated or newly applied rejections.
Applicants argued that cluster headache (CH) and migraine have important differences in pathophysiological mechanisms and require different management and treatment approaches due to the unique characteristics of each. Applicant further argued that due to such differences, treatments for other painful conditions including Weg’s treatment of migraine cannot be expected to be effective in treatment of CH.
In response, while cluster headaches may differ in pathophysiological mechanisms from migraine as applicant asserted, that difference does not negate the fact that ketamine is effective for treating chronic cluster headaches as evidenced by Granata. Also, Weg teaches that nasal administration of ketamine is particularly effective for treating episodic and breakthrough pain conditions and intractable pain (pain that can’t be stopped, even with medication) as stated above. Weg further discloses that intranasal ketamine achieved more satisfactory pain management for a patient suffering from intractable bladder pain, which are not controlled by a variety of narcotics, analgesics, and sedatives. Thus, one of ordinary skill in the art would have expected that ketamine would be useful for treating pain conditions which are not treatable by general pain killers such as opioid (narcotics) and non-steroidal anti-inflammatory drugs. In addition, cluster headaches may have different pathology from migraine taught by Weg, but they all have pain origin in the brain and thus need for brain targeting. Weg teaches intranasal administration is effective route for the treatment of headache conditions which requires ketamine delivered to the brain. Also, Singh et al. teach that intranasal administration has been proposed as a promising delivery route for ketamine because it allows for outpatient maintenance dosing, is a needle-free option, and has greater bioavailability compared to the oral route due to the absence of a hepatic first-pass. Accordingly, one of ordinary skill in the art, who are looking for alternative route to intravenous injection for the treatment of cluster headaches taught by Granata, would have been motivated to use intranasal route taught by Weg and WO 2019/126108 with reasonable expectation of success.
Second, Applicant argued that Granata does not teach acute treatment with i.v. ketamine during attacks and merely suggest a prophylactic use of ketamine for long term management of CH while claims as amended require both self-administration and administration at onset of a CH episode. Applicant further argued that the complexities of treating serious side effects in Granata would teach away from self-administration of ketamine.
In response, Weg already teaches that administration of an analgesic dose of ketamine advantageously allows for patient self- administration of the drug, which provides for pain management on an outpatient basis (see column 3, lines 4-7). Weg further teaches that intranasal administration of ketamine allows for effective pharmacokinetics with low doses of the drug, thus avoiding dysphoria or other side effects associated with bolus i.v. or i.m. dosing. In addition, Weg teaches that intranasal administration of ketamine can relieve or alleviate episodes of acute breakthrough pain that can occur in a chronic pain condition (see col 5, lines 23-26). Thus, one of ordinary skill in the art would have reasonably expected that intranasal ketamine would avoid the side effects associated with i.v. ketamine and would be effective for treating headache upon onset of a CH episode via self-administration of ketamine due to its fast action as taught by Weg.
As to the arguments regarding self-administration and one-dose container (single use container), WO2019126108 does teach the use of intranasal ketamine in a single-use device which is configured to administer the esketamine in two or more sprays and from about 28 to about 84 mg of esketamine. Thus, one of ordinary skill in the art would have been motivated to use a single-use device containing a single spray amount for further improving dosing precision in administering the intranasal ketamine formulation for the treatment of cluster headache because the device makes it easier to deliver the ketamine nasal formulation with high dosing precision and reliability for self-administration by patients as evidenced by WO2019126108. As to the amount in each dose, Weg and WO 2019126108 disclose the total daily dosage, the amount in each dose (14-16 mg), the number of divided doses and the interval between the doses, which overlap or are very closer to those claimed. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Similarly, a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985). See MPEP 2144.05 Obviousness of Ranges. In addition, it is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. “[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); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”)
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). It is important to note that in an obvious rejection, it is not necessary that one reference addresses any limitation in a particular claim but that the references, when combined, do so. In this case, Granata explicitly teaches that ketamine is effective for treating chronic cluster headaches and the only difference is administration route. Also, Weg and WO2019126108 already teaches the feasibility and advantages of an intranasal composition such as nasal spray in a single-use device for delivering ketamine to the brain in the treatment of intractable headache conditions. Thus, the skilled artisan would have reasonably expected that intranasal delivery of ketamine would be effective for treating the same condition similarly to intravenous ketamine in the absence of evidenced to the contrary. One of ordinary skill in the art would have been motivated to use the ketamine aqueous solution in a nasal spray taught by Weg and WO 2019126108 in the treatment of chronic cluster headache, especially for those patients who have onset of a cluster headache episode and thus need fast action of the drug while avoiding side effects associated with a bolus dose of ketamine and for improving patient’s convenience since intranasal administration does not need medical intervention and can be self-administered by the patient on needed-basis as evidenced by Weg.
The examiner recognizes that obviousness can only be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988) and In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992). It is also noted that "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
For the foregoing reasons, Applicant’s arguments have not been found to be persuasive.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611