Children's Hospital Medical Center

Patent Trials and Appeals Board

Feb 18, 2022

2021001520 (P.T.A.B. Feb. 18, 2022)

UNITED STATES PATENT AND TRADEMARK OFFICE UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www.uspto.gov APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 15/335,547 10/27/2016 Craig Andrew Erickson 0010872.0641067 1066 26874 7590 02/18/2022 FROST BROWN TODD LLC 3300 Great American Tower 301 East Fourth Street Cincinnati, OH 45202 EXAMINER FAY, ZOHREH A ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 02/18/2022 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): patents@fbtlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte CRAIG ANDREW ERICKSON, LOGAN KRISTEN WINK, and TORI LYNN SCHAEFER Appeal 2021-001520 Application 15/335,547 Technology Center 1600 Before ULRIKE W. JENKS, TINA E. HULSE, and RACHEL H. TOWNSEND, Administrative Patent Judges. TOWNSEND, Administrative Patent Judge. DECISION ON APPEAL Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s decision to reject claims to an intranasal delivery device comprising S-ketamine as being obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42. Appellant identifies the real party in interest as Children’s Hospital Medical Center, Cincinnati, Ohio. (Appeal Br. 3.) Appeal 2021-001520 Application 15/335,547 2 STATEMENT OF THE CASE Appellant’s Specification notes that “[o]ver the last decade there has been a sharp rise in reported cases of Autism Spectrum Disorder (ASD).” (Spec. ¶ 2.) In addition, it is noted that “[d]espite extensive pharmaceutical research, there are no FDA-approved medications for treatment of the core social impairment associated with ASD.” (Id.) Appellant’s invention is directed to the intranasal delivery of S-ketamine to treat patient’s with ASD. (Id. ¶ 3.) Claims 16 and 49, reproduced below, are illustrative of the claimed subject matter: 16. An intranasal delivery device comprising a composition suitable for intranasal delivery, wherein the composition comprises greater than 95% of S-ketamine, wherein said delivery device delivers a unit dose of about 10 mg of atomized S- ketamine per 0.1 cc of spray. 49. An intranasal delivery device for use in treating autism spectrum disorder in a subject comprising: a composition suitable for intranasal delivery, wherein the composition comprises S-ketamine, wherein said delivery device delivers a unit dose of about 10 mg of atomized S- ketamine per 0.1 cc of spray, and instructions for use, wherein a subject having autism spectrum disorder is instructed to nasally administer said composition according to one of the frequencies selected from the group consisting of daily, weekly, and every two to seven days. (Appeal Br. 16-17.) Appeal 2021-001520 Application 15/335,547 3 The prior art relied upon by the Examiner is: Name Reference Date Singh et al. US 2014/0093592 A1 Apr. 3, 2014 Charney et al. WO 2007/111880 A2 Oct. 4, 2007 The following ground of rejection by the Examiner is before us on review: Claims 16, 17, 39, 40, 42, 43, and 46-49 under 35 U.S.C. § 103(a) as unpatentable over Charney and Singh. DISCUSSION The Examiner found that Charney teaches intranasal administration of a ketamine solution where the “concentration” administered is between 0.1 mg/kg to 3 mg/kg per day. (Final Action 3 (citing Charney Abstr. and ¶ 15).) The Examiner also found that Charney teaches “concentrations from 2 mg and between 2 mg and 250 mg.” (Final Action 3 (citing Charney ¶ 76).) Moreover, the Examiner found that Charney describes a device for containing the ketamine composition, which device aerosolizes the aerosol formulation of the ketamine solution and delivers a metered dosage. (Ans. 7 (citing Charney ¶ 94).) The Examiner found that Singh teaches the use of S-ketamine at a “concentration” between 0.01mg to 1000 mg, and that the S-ketamine can be administered intranasally as an aerosol or spray, and in conjunction with other components, such as serotonin reuptake inhibitors, antipsychotics stimulant and alpha 2 agonists. (Final Action 3 (citing Singh ¶¶7, 17, 18, 33, 46,48, 57); Ans. 7). The Examiner further found that Singh teaches that S- ketamine has “higher potency or affinity for NMDA reception.” (Ans. 7.) Appeal 2021-001520 Application 15/335,547 4 The Examiner determined that it would have been obvious to one of ordinary skill in the art to use S-ketamine in the Charney formulation given the teachings in Singh. (Final Action 3) The Examiner recognized that the prior art does not expressly teach the claim requirement that the delivery device deliver 10 mg of atomized S-ketamine per 0.1 cc of spray. (Id.) However, the Examiner stated that “Singh teaches the amounts delivered is 0.01 mg-1000 mg. Such amounts encompass[] the amounts taught by the instant application.” (Final Action 4.) And the Examiner found that such limitation of the dosage per spray “does not affect the overall amounts that a patient is going to receive” as taught by the prior art, “considering that a person skilled in the art can adjust the amount by getting many sprays or less sprays.” (Id. at 3.) The Examiner also recognized that the prior art does not teach the instructions required by claim 49. (Id.) However, the Examiner determined that instructions that are stored with the container that includes the claimed composition “does not create a patentably distinct composition.” (Id.) We agree with the Examiner that the intranasal delivery device as claimed is rendered obvious by the teachings of Charney and Singh. We note that the claimed device does not recite any structural elements. Instead, it recites that a composition of S-ketamine is part of the “device” and recites a functional characteristic of the device, namely that it “delivers” a particular unit dose size of atomized S-ketamine, i.e., 10 mg, in a particular volume of spray, i.e., 0.1 cc. Appellant’s Specification does not describe any particular device having an S-ketamine contained within it or that functions as claimed. Indeed, the only description of a device for delivering 10 mg of atomized Appeal 2021-001520 Application 15/335,547 5 ketamine in a 0.1 cc spray is the following statement repeated twice in the Specification: “Ketamine will be compounded into a mucosal atomization device which delivers 10mg of atomized ketamine per 0.1cc spray.” (Spec. ¶¶ 93, 195.) Similarly, the Specification describes a mucosal atomization device that delivers 20 mg of atomized ketamine per 0.1cc spray. (Spec. ¶¶ 40, 44.) Nothing in the Specification, however, states or suggests that a device capable of delivering the claimed amount of atomized ketamine in a 0.1 cc spray is new or novel.2 In light of this, we find it reasonable for the Examiner to conclude that atomization devices available in the prior art were capable of delivering 10 mg of ketamine in 0.1 cc of spray. (See Answer 6.) In addition, Charney teaches the use of available prior art devices (including some that are “commercially available”), which, absent evidence to the contrary, appear to be capable of delivering the claimed amount in any 2 If a specific device to deliver a 0.1 cc volume containing 10 mg of ketamine were required, which was not known in the prior art, Appellant would be required to describe such a device in the Specification to satisfy both the enablement and written description requirements of 35 U.S.C § 112. See, e.g., Trustees of Boston University v. Everlight Electronics Co., Ltd., 896 F.3d 1357, 1363-65 (Fed. Cir. 2018) (to “exclude others from what [one] regarded as [one’s] invention, [one’s] patent needed to teach the public how to make and use that invention,” and while knowledge of the prior art and routine experimentation can be used to “fill gaps, interpolate between embodiments, and perhaps even extrapolate beyond the disclosed embodiments, depending upon the predictability of the art . . . this gap- filling is merely supplemental; it cannot substitute for a basic enabling disclosure.”); Carnegie Mellon University v. Hoffman-La Roche, 541 F.3d 1115, 1122 (Fed. Cir. 2008) (to satisfy the written description requirement showing with reasonable clarity that, as of the filing date sought, the applicant was in possession of the invention, the applicant must demonstrate such possession “by disclosure in the specification of the patent”). Appeal 2021-001520 Application 15/335,547 6 volume of liquid known to be used with atomization devices capable of delivering metered doses as discussed below. (See Charney ¶¶ 94, 98.) Charney describes that (1) atomization3 devices for nasal administration that deliver a metered dose from a chamber of defined volume may be used to deliver a ketamine solution (Charney ¶ 94; see Ans. 6) or (2) “a plastic squeeze bottle with an aperture or opening dimensioned to aerosolize an aerosol formulation by forming a spray when squeezed” that “[p]referably” “will provide a metered amount of the aerosol formulation, for administration of a measured dose of the drug” may be used (id. ¶ 95). Charney further states “[o]ne of ordinary skill in the art can readily determine a volume or weight of aerosol corresponding to this dosage [i.e., 0.01 mg per kg body weight of the mammal up to about 1 mg per kg body weight of said mammal,] based on the concentration of ketamine in an aerosol formulation of the invention.” (Id. ¶ 98 (emphasis added).)4 Charney also teaches a 10 mg dose, among other dosages between 2 mg and 250 mg, for intranasal delivery. (Charney ¶ 76; see Final Action 35.) Thus we agree with the Examiner that the prior art teaches or at least suggests a device that 3 Charney teaches that the term “aerosol refers to the particlization or atomization of a formulation of the invention and its suspension in the air.” (Charney ¶ 86; see Ans. 6 (noting ¶ 86 of Charney and that it teaches an aerosol refers to “the atomization of suspension in the air.”).) Thus, an aerosol device in Charney is an atomization device. 4 Thus, we do not agree that there is no disclosure “anywhere else in Charney” of mg of atomized ketamine. 5 The Examiner further pointed out that Charney teaches that 10-50 mg of ketamine has been administered through intranasal administration in incremental 10 mg doses, every 90 seconds. (Ans. 5 (citing Charney ¶ 12).) Appeal 2021-001520 Application 15/335,547 7 contains ketamine solution in a liquid that includes a 10 mg dosage in a defined volume for aerosolized intranasal delivery. (See Ans. 6.) Although a metered dose volume of 0.1 cc for a 10 mg dosage amount is not specifically identified as a metered dose volume for an aerosolization device in Charney, we conclude that Charney’s teachings that one of ordinary skill in the art can readily determine a volume to deliver a “dosage” up to 1 mg per kg body weight of ketamine in an aerosol formulation (Charney ¶ 98) indicates that a device capable of delivering a metered dose volume of 0.1 cc for delivering a dosage of 10 mg of ketamine would have been obvious to one having ordinary skill in the art. “[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 (CCPA 1955). Even if it is the case, as urged by Appellant (Reply Br. 4), that Charney paragraph 59 refers to an overall amount of ketamine dosed to a patient being between 0.01 to approximately 1 mg/kg and not a unit dose that includes 10 mg ketamine, Charney teaches at paragraph 12, referenced by the Examiner (Ans. 5), that “10-50 mg of ketamine has been administered through intranasal administration in incremental 10 mg doses, every 90 seconds.” (Charney ¶ 12.) In addition, in a paragraph also referenced by the Examiner (Final Action 3), Charney teaches formulations “containing intransal . . . doses of . . .10 mg” is “specifically contemplated.” (Charney ¶ 76.) Also, for the reasons discussed, we do not find Appellant’s argument that Charney does not “teach a specific concentration” (Appeal Br. 7-9) to be persuasive of non-obviousness. Although we recognize the Examiner Appeal 2021-001520 Application 15/335,547 8 repeatedly misused the term “concentration” to refer to the dosage amount, we find this to be harmless error in light of the specific statements in Charney that a volume of aerosol to arrive at a concentration of ketamine in an aerosol formulation with a dosage amount between about 0.01 mg per kg body weight of the mammal up to about 1 mg per kg body weight of said mammal “can readily [be] determine[d]” by one of ordinary skill in the art (Charney ¶ 98). And although the Examiner did state that the art does not specifically teach 10 mg/0.1cc and asserted that “a person skilled in the art can adjust the amounts by getting many sprays or less sprays” in concluding that the art renders obvious Appellant’s claimed device (Appeal Br. 11-12), we need not and do not rely on that assertion in concluding the Examiner’s rejection for obviousness is supported. Our position regarding “workable ranges” for the concentration claimed being obvious is not a new ground of rejection because such was at least one thrust of the Examiner’s rejection regarding the concentration limitation. In particular, the Examiner pointed to various teachings in Charney describing ranges of dosage amounts of ketamine solution to be administered in a “defined volume.” (Ans. 6; see also Ans. 7 (“spray of the prior art delivers the same amount of ketamine as the claimed invention, regardless of the volume of each spray”).) Thus, Appellant had an opportunity to respond to the foregoing in its Reply Brief. In re Kronig, 539 F.2d 1300, 1302 (CCPA 1976) (“[T]he ultimate criterion of whether a rejection is considered ‘new’ in a decision by the board is whether appellants have had fair opportunity to react to the thrust of the rejection.”). “While the Board’s explanation may go into more detail than the examiner’s, that does Appeal 2021-001520 Application 15/335,547 9 not amount to a new ground of rejection.” In re Adler, 723 F.3d 1322, 1328 (Fed. Cir. 2013). Regarding the requirement that the composition comprise greater than 95% of S-ketamine, we agree with the Examiner that Singh’s teachings render obvious the provision of S-ketamine in the composition contained within the atomization device taught by Charney. In particular, Singh teaches that S-ketamine “has higher potency or affinity for the NMDA reception” and “is available for medical use under the brand name KET- ANEST S.” (Singh ¶ 7.) Moreover, Singh teaches that the compositions of S-ketamine for treatment can be dosed in a number of different manners including intranasally as a metered aerosol in a variety of dosage amounts including 10 mg. (Id. ¶¶ 33, 48, 57.) Consequently, while it does not use the term “atomized-S ketamine” (Appeal Br. 9), Singh certainly teaches such a form, and thus, we do not find persuasive Appellant’s non-obviousness argument that Charney does not teach atomized S-ketamine. “Non- obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references. . . . [The reference] must be read, not in isolation, but for what it fairly teaches in combination with the prior art as a whole.” In re Merck & Co., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Regarding claim 49, we note that the preamble language “for use in treating autism spectrum disorder” recited in that claim (Appeal Br. 9-10) does not distinguish the claimed device. “[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure.” Catalina Mktg. Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002); see also In re Schreiber, 128 F.3d Appeal 2021-001520 Application 15/335,547 10 1473, 1477 (Fed. Cir. 1997) (“It is well settled that the recitation of a new intended use for an old product does not make a claim to that old product patentable.”). Regarding claim 49’s “instructions for use,” (see Appeal Br. 9-10), we note “[c]laim limitations directed to printed matter are not entitled to patentable weight unless the printed matter is functionally related to the substrate on which the printed matter is applied.” Praxair Distribution, Inc. v. Mallinckrodt Hospital Prods IP Ltd., 890 F.3d 1024, 1031-32 (Fed. Cir. 2018). The claimed instructions for use here do not in any way affect or limit how any physical components (none of which are specifically identified by any claim language) of the claimed device actually function. Nor do the claimed instructions affect or limit the structure (none of which is specifically identified by any claim language) of the claimed device. Consequently, we do not find the instruction to be functionally or structurally related to any physical component of the claimed device. Praxair, 890 F.3d at 1032 (“We have held that merely adding an instruction sheet or other informational content to a drug product is not sufficient to create a functional relationship, even if required by the FDA for approval.”). The instructions regarding administration frequency are related to the intended use of the device and do not impart any structural features to it. Thus, the instructions for use are not entitled to any patentable weight. Id. at 1031. We also do not find Appellant’s arguments about the Examiner’s alleged improper use of official notice to warrant reversal. (Appeal Br. 11- 15.) In particular, we find the argument to be moot because (a) we do not rely on the Examiner’s “number of sprays” rationale; (b) we find the Appeal 2021-001520 Application 15/335,547 11 concentration of 10 mg / 0.1 cc spray to be obvious from the teachings of Charney, as outlined above; and (c) any limitations directed to autism are not entitled to any patentable weight as the claims at issue are device claims, not method claims. Thus, we affirm the Examiner’s rejection of claims 16 and 49 as being obvious from the teachings of Charney and Singh. Claims 17, 39, 40, 42, 43, 46-48 have not been argued separately and therefore fall with claim 16. 37 C.F.R. § 41.37(c)(1)(iv). DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 16, 17, 39, 40, 42, 43, 46-49 103 Charney, Singh 16, 17, 39, 40, 42, 43, 46-49 TIME PERIOD FOR RESPONSE No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED