DETAILED CORRESPONDENCE
This office action is in response to applicant’s filing dated April 12, 2024.
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 .
Status of Claims
Claims 1-14 are pending in the instant application.
Priority
The present application is a CON of U.S. Application No. 18/242,236 filed on September 5, 2023, which is a CON of U.S. Application No. 15/519,463 filed on April 14, 2017, which is a national stage entry of PCT/US15/55828 filed on October 15, 2015, which claims benefit of U.S. Provisional Application No. 62/064,205 filed on October 15, 2014.
Drawings
Acknowledgement is made of the drawings received on April 12, 2024.
The drawings are objected to because:
Figures 1-3 are pixelated and blurry. The axis labels are difficult to read and text directly below the graphs is blurry.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
In the instant case, the abstract contains language that can be implied, “There is provided…”
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 2, and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henwood et al (WO 2010/132882 A2).
Regarding claims 1, 2, 11, and 12, Henwood teaches a pharmaceutical composition comprising dexmedetomidine or a pharmaceutically acceptable salt or pro-dmg thereof, said pharmaceutical composition being configured and adapted for transmucosal administration to a mammal (claim 21), wherein said pharmaceutical composition is configured and adapted for sublingual administration (claim 22).
With regard to the limitation “for treating a sleep disorder,” such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e. an intent to use the disclosed pharmaceutical composition as treatment for a sleep disorder), which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. When reading the preamble in the context of the entire claim, the recitation “for treating a sleep disorder” is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Regarding claim 13, Henwood teaches the pharmaceutical composition is configured and adapted for transmucosal administration by applying a spray of said composition to a mucous membrane within oral cavity of said mammal.
Thus, the teachings of Henwood anticipate the composition of claims 1, 2, and 11-13.
Claims 1, 2, 4-7, and 11-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Armer et al (US 2010/0196286 A1).
Regarding claims 1, 2, 4-6, 11, 13, and 14, Armer teaches a method of inducing arousable sedation in a subject comprising administering a therapeutically effective amount of an α2-adrenergic composition comprising an α2-adrenergic agonist (claim 1), wherein the subject has insomnia and the arousable state of sedation is induced to treat insomnia, wherein the α2-adrenergic agonist is dexmedetomidine (claim 6). Armer teaches devices that may be employed with one or more of the methods described herein include sublingual spray actuators [0015].
Regarding claims 7 and 12, Armer teaches the subject has sleep onset insomnia and the arousable state of sedation is induced to treat the sleep onset insomnia (claim 3).
Thus, the teachings of Henwood anticipate the composition of claims 1, 2, 4-7, and 11-14.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 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 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 3, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Armer et al (US 2010/0196286 A1) as applied to claims 1, 2, 4-7, and 11-14 above.
Armer teaches all the limitations of instant claims 3 and 8, except wherein the dexmedetomidine is in a range of about 0.1 mg to about 5 mg. However, Armer does teach wherein the α2-adrenergic agonist composition is administered to the subject at a dosage in the range of about 0.01 μg/kg to about 300 μg/kg (claim 16). Assuming an average weight of an adult human is about 60 kg, an amount of 0.01 μg/kg to about 300 μg/kg is about 0.6 μg -18 mg. MPEP 2144.05 states: 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003). In the instant case, the amounts taught by Armer overlap the instantly claimed amounts.
Similarly, regarding instant claim 9, Armer does not explicitly teach an effective time for treatment is in the range of from about 3 to about 30 minutes. However, Armer does teach administering a therapeutically effective amount of an α2-adrenergic agonist composition to the subject using a non-injectable route of administration, to initiate an arousable state of sedation within the subject in about 30 minutes or less. 30 minutes or less reads on a range of 0-30 minutes. Thus, the treatment time taught by Armer overlaps the instantly claimed range. MPEP 2144.05 states: 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Armer et al (US 2010/0196286 A1) as applied to claims 1-9 and 11-14 above, and further in view of Coderre et al (WO 2011/127586 A1).
Regarding claim 10, Armer teaches a method for treating insomnia comprising administering a therapeutically effective amount of a composition comprising dexmedetomidine, wherein the composition is administered with a device such as a sublingual spray actuator. Archer does not teach the method is suitable for patients having disturbed sleep due to chronic pain.
However, Coderre teaches a topical composition for the treatment of pain comprising a therapeutically effective amount of an alpha2-adrenergic agonist (claim 1) wherein the alpha2-adrenergic agonist is dexmedetomidine (claim 5), wherein the pain is neuropathic pain (claim 15). Neuropathic pain reads on chronic pain.
As such, since Armer teaches a method for treating insomnia comprising administering a therapeutically effective amount of a composition comprising dexmedetomidine with a device such as a sublingual spray actuator; and since Coderre teaches dexmedetomidine is useful for treating chronic pain; it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to modify the method of treating insomnia taught by Armer to treat subjects suffering from insomnia due to chronic pain, since the cited art teaches dexmedetomidine is useful for treating insomnia and chronic pain.
Taken together, all this would result in the method of claim 10 with a reasonable expectation of success.
Conclusion
Claims 1-14 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/Primary Examiner, Art Unit 1628
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