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
Claims 72-100 are pending.
Application Priority
This application filed 06/25/2024 is a CON of 17/881,191 filed on 08/04/2022 which is a DIV of PAT 11458091 filed on 05/15/2019 which is a national stage entry of PCT/US17/60964 , International Filing Date: 11/09/2017, claims priority to 62/424,378, filed 11/18/2016.
Information Disclosure Statement
No information disclosure statement(s) (IDS) filed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
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.
Claims 72-100 are rejected under 35 U.S.C. 103 as being unpatentable over Crystal et al. (US20150258019A1) in view of Maggio et al. (US 20090110735 A1).
A pharmaceutical formulation for intranasal administration, comprising: (a) from about 1 mg to about 4 mg of nalmefene or a pharmaceutically acceptable salt thereof; (b) from about 0.1 mg to about 2.5 mg of dodecyl maltoside; (c) from about 0.2 mg to about 1.2 mg of sodium chloride; (d) from about 0.005 mg to about 1 mg of a preservative; (e) from about 0.1 mg to about 0.5 mg of disodium edetate; and (f) water in an amount sufficient to achieve a final volume of about 50 to about 250 microliters.
Crystal et al. teaches a single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient for treating opioid overdose or its symptom by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which comprise an opioid antagonist (abstract and claim1). Opioid antagonist listed include Nalmefene hydrochloride [0054]. The composition is an aqueous solution of about 100 μL comprising: about 2 mg or about 4 mg an opioid antagonist; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a preservative; between about 0.01 mg and about 0.05 mg of a stabilizing agent; an amount of an acid sufficient to achieve a pH or 3.5-5.5. The isotonicity agent is NaCl, the stabilizing agent is disodium edetate ([0233], claim 1). Literature data has indicated that naloxone is sensitive to environmental factors, such as air, light and colours in certain vials, which may induce a risk for degradation. Consequently disodium edetate was added to the above formulation [0347]. The use is for athe complete or partial reversal of narcotic depression, including respiratory depression, induced by opioids selected from: natural and synthetic narcotics, propoxyphene, methadone, nalbuphine, pentazocine and butorphanol.
The reference fails to teach the absorption enhancer nor the amount of the Stabilizing Agent: disodium edetate.
Maggio et al. teaches Exemplary preservatives include ethylene diamine tetraacetic acid (EDTA), benzalkonium chloride, and sodium azide or dodecyl maltoside.
It would have been obvious to one or ordinary skill in the art at the time of filing to interchange benzalkonium chloride and dodecyl maltoside and increase the amount of the stabilizing agent. The motivation comes from the teaching in Crystal et al. that a preservative is useful in the intranasal formulation, and that in a case where sensitivity to environmental factors, such as air, light and colors in certain vials, may induce a risk for degradation, disodium edetate was added; and from Maggio et al. that benzalkonium chloride and dodecyl maltoside are both preservatives. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar preservative and decreased degradation properties.
Claims 72-100 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (CN1634062A) in view of Crystal et al. (US20150258019A1) and Maggio et al. (US 20090110735 A1).
Zhang et al. teaches nalmefene preparation to be administered through nasal cavity, which comprises nalmefene, namefene free alkali or other pharmaceutically acceptable medicinal salt of nalmefene and absorption promoting agent (abstract). The reference teaches nalmefene hydrochloride (claim 1). The nalmefene of 0.2-80% of the formulation.
While the reference teaches an absorption enhancer, the reference fails to specify the specific absorption enhancer, nor an isotonicity agent or Stabilizing Agent: disodium edetate.
Crystal et al. teaches a single-use, pre-primed device adapted for nasal delivery of a pharmaceutical composition to a patient by one actuation of said device into one nostril of said patient, having a single reservoir comprising a pharmaceutical composition which comprise an opioid antagonist (abstract and claim1). Opioid antagonist listed include Nalmefene hydrochloride [0054]. The composition is an aqueous solution of about 100 μL comprising: about 2 mg or about 4 mg an opioid antagonist; between about 0.2 mg and about 1.2 mg of an isotonicity agent; between about 0.005 mg and about 0.015 mg of a preservative; between about 0.01 mg and about 0.05 mg of a stabilizing agent; an amount of an acid sufficient to achieve a pH or 3.5-5.5. The isotonicity agent is NaCl, the stabilizing agent is disodium edetate ([0233], claim 1). Literature data has indicated that naloxone is sensitive to environmental factors, such as air, light and colours in certain vials, which may induce a risk for degradation. Consequently disodium edetate was added to the above formulation [0347]. The reference teaches therapeutically effective amount is delivered essentially by a first actuation of said device into a first nostril of said patient and a second actuation of said device into a second nostril of said patient and wherein a first volume of said pharmaceutical composition is present in a first reservoir and a second volume of said pharmaceutical composition is present in a second reservoir, and wherein said therapeutically effective amount is delivered essentially by a first actuation of said device into a first nostril of said patient and a second actuation of said device into a second nostril of said patient [0137].
Maggio et al. teaches Exemplary preservatives include ethylene diamine tetraacetic acid (EDTA), benzalkonium chloride, and sodium azide or dodecyl maltoside.
It would have been obvious to one or ordinary skill in the art at the time of filing to interchange benzalkonium chloride and dodecyl maltoside and increase the amount of the stabilizing agent. The motivation comes from the teaching in Crystal et al. that a preservative is useful in the intranasal formulation, and that in a case where sensitivity to environmental factors, such as air, light and colors in certain vials, may induce a risk for degradation, disodium edetate was added; and from Maggio et al. that benzalkonium chloride and dodecyl maltoside are both preservatives. Hence, a skilled artisan would have reasonable expectation of successfully achieving similar preservative and decreased degradation properties.
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 §§ 706.02(l)(1) - 706.02(l)(3) 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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 72-100 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of US PAT 11458091.
The conflicting claims are anticipated over US PAT 11458091 because both applications disclose pharmaceutical formulation for intranasal administration, comprising: about 3% (w/v) nalmefene hydrochloride; between about 0.1% (w/v) and about 0.5% (w/v) dodecyl maltoside; between about 0.2% (w/v) and about 1.2% (w/v) NaCl between about 0.13% (w/v) and about 0.67% (w/v) disodium edetate; between about 0.001% (w/v) and about 0.1% (w/v) benzalkonium chloride; an amount of an acid or base sufficient to achieve a pH of between 3.5 and 5.5; and water in an amount sufficient to achieve a final volume of about 50 μL to about 200 μL.
Claims 72-100 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of US PAT 12290596.
The conflicting claims are anticipated over US PAT 12290596 because both applications disclose pharmaceutical formulation for intranasal administration, comprising: about 3% (w/v) nalmefene hydrochloride; between about 0.1% (w/v) and about 0.5% (w/v) dodecyl maltoside; between about 0.2% (w/v) and about 1.2% (w/v) NaCl between about 0.13% (w/v) and about 0.67% (w/v) disodium edetate; between about 0.001% (w/v) and about 0.1% (w/v) benzalkonium chloride; an amount of an acid or base sufficient to achieve a pH of between 3.5 and 5.5; and water in an amount sufficient to achieve a final volume of about 50 μL to about 200 μL.
Claims 72-100 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of US 12594388 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both applications disclose nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt; NaCl;about benzalkonium chloride; disodium edetate; dodecyl maltoside. The main difference between the instant application and the prior application is that the prior application does not specify the amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a multi-use device for delivering a predetermined amount of at least one substance to a body orifice with the same amounts of components claimed within the same range of the prior art reference.
Claims 72-100 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of US 11318107 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both applications disclose nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt; NaCl;about benzalkonium chloride; disodium edetate; dodecyl maltoside. The main difference between the instant application and the prior application is that the prior application does not specify the amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a multi-use device for delivering a predetermined amount of at least one substance to a body orifice with the same amounts of components claimed within the same range of the prior art reference.
Claims 72-100 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. : 19/371026.
The conflicting claims are anticipated over 19/371026 because both applications disclose 3.0 about 10.0 nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt;about 0.8% (w/v) of NaCl;about 0.005% to about 0.05% (w/v) benzalkonium chloride;about 0.2 mg disodium edetate; about 0.1% (w/v) to about 0.5% (w/v) dodecyl maltoside.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 72-100 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. : 19/170660.
The conflicting claims are anticipated over 19/170660 because both applications disclose 3.0 about 10.0 nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt;about 0.8% (w/v) of NaCl;about 0.005% to about 0.05% (w/v) benzalkonium chloride;about 0.2 mg disodium edetate; about 0.1% (w/v) to about 0.5% (w/v) dodecyl maltoside.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 72-100 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of US 9895444 B2.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both applications disclose nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt; NaCl;about benzalkonium chloride; disodium edetate; dodecyl maltoside. The main difference between the instant application and the prior application is that the prior application does not specify the amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a multi-use device for delivering a predetermined amount of at least one substance to a body orifice with the same amounts of components claimed within the same range of the prior art reference.
Claims 72-100 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. : 19/371026.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both applications disclose 3.0 about 10.0 nalmefene hydrochloride, a hydrate thereof, or another pharmaceutically acceptable salt;about 0.8% (w/v) of NaCl;about 0.005% to about 0.05% (w/v) benzalkonium chloride;about 0.2 mg disodium edetate; about 0.1% (w/v) to about 0.5% (w/v) dodecyl maltoside. The main difference between the instant application and the prior application is that the prior application does not specify the amounts.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to make a multi-use device for delivering a predetermined amount of at least one substance to a body orifice with the same amounts of components claimed within the same range of the prior art reference.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/LAYLA SOROUSH/Primary Examiner, Art Unit 1622
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