DETAILED ACTION
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 .
This Office action is responsive to Applicant’s preliminary amendment, filed 07 March 2024, in which claims 1-15 are canceled and new claims 16-33 are added.
This application is a domestic application, filed 07 March 2024; claims benefit as a CON of 17/811,488, issued as Patent 12,011,453, filed 08 July 2022; claims benefit as a CON of 16/770,482, issued as Patent 11,413,298, which is a 371 of PCT/EP2018/097060, filed 28 Dec 2018; and claims benefit of foreign priority document EP 18154088.1, filed 30 Jan 2018. This foreign priority document is in English.
Claims 16-33 are pending in the current application and are examined on the merits herein.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/770,482, filed on 05 June 2020.
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 (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 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 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 16-23 are rejected under 35 U.S.C. 103 as being unpatentable over Marchase et al. (US 5,643,883, issued 01 July 1997, cited in PTO-892) in view of Yao et al. (US 2012/0238511, published 20 Sep 2012, cited in PTO-892).
Marchase et al. teaches a composition of matter comprising an inhibitor of glucose-6-phosphate uptake (abstract). In embodiments the inhibitor is 2-deoxyglucose (claim 4 at column 18; column 5, lines 50-65). Such inhibitors are generally administered to said cell at a concentration of from about 0.1 mM to about 20 mM (column 6, lines 1-10), addressing limitations of claims 16 and 22-23. Generally, the inhibitor is given by a route of administration selected from the group consisting of oral administration, intranasal administration and inhalation administration (column 6, lines 1-10). Marchase et al. teaches the embodiment of a pharmaceutical composition, comprising an inhibitor of glucose-6-phosphate uptake and a pharmaceutically acceptable carrier (column 2, lines 55-60). A person having ordinary skill in this art would readily be able to determine, without undue experimentation, the appropriate dosages and routes of administration of the inhibitor of glucose-6-phosphate uptake (column 5, lines 35-40).
Marchase et al. does not specifically disclose the structure of the pharmaceutical composition appropriate for intranasal administration (claim 16 and 23).
Yao et al. teaches pharmaceutical compositions containing 2-deoxy-D-glucose (2-DG). The compositions can be administered orally, enterally, transdermally, transmucosally, intranasally, or parenterally (abstract). The compound can be combined with one or more pharmaceutically acceptable carriers, additives, and/or excipients for oral, enteral, transdermal, transmucosal, intranasal, or parenteral administration. The compound can be administered using a topical spray; or via the pulmonary or nasal route, such as an inhalation spray (page 4, paragraph 45 and 52). The pharmaceutical compositions can include carriers such as water or saline. The liquid carrier may contain other suitable pharmaceutically acceptable additives such as buffers and preservatives (page 4, paragraph 49). Injectable preparations such as sterile injectable aqueous or oleaginous suspensions may be formulated according to the known art using suitable dispersing or wetting agents and suspending agents. Among the acceptable vehicles and solvents that may be employed are water, Ringer's solution, and isotonic sodium chloride solution (page 5, paragraph 53).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Marchase et al. in view of Yao et al. in order to formulate the pharmaceutical composition of Marchase et al. using the teachings of Yao et al. One of ordinary skill in the art would have been motivated to combine Marchase et al. in view of Yao et al. with a reasonable expectation of success because both Marchase et al. and Yao et al. are drawn to pharmaceutical compositions containing 2-deoxy-D-glucose suitable for intranasal administration, Marchase et al. suggests a person having ordinary skill in this art would readily be able to determine the appropriate formulation for the routes of administration without undue experimentation, and Yao et al. teaches known pharmaceutically acceptable carriers, additives, and/or excipients for formulating pharmaceutical compositions containing 2-deoxy-D-glucose such as in the form of an intranasal spray. Regarding claim 17, Yao et al. teaches sterile injectable aqueous or oleaginous suspensions may be formulated according to the known art, and it would have been obvious to modify the teachings in order to formulate the nasal spray formulation to be sterile in order to provide the same known advantages of a pharmaceutical composition being sterile. Regarding claim 21, Marchase et al. teaches the inhibitor concentration of from about 0.1 mM to about 20 mM and teaches a person having ordinary skill in this art would readily be able to determine the appropriate dosages without undue experimentation, suggesting it would have been routine experimentation to determine the amount of the optimal dose. See also MPEP 2144.05 at II. providing ‘“[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)’ In this case Marchase et al. teaches the general conditions and that a person having ordinary skill in this art would have selected the workable dosage without undue experimentation.
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 16-23 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,413,298 (reference patent) in view of Yao et al. (US 2012/0238511, published 20 Sep 2012, cited in PTO-892).
Reference claims 1-12 of the reference patent are drawn to a method comprising obtaining a pharmaceutically acceptable formulation comprising 2 deoxy-D-glucose and administering an effective amount of the formulation, making obvious possession of the formulation so administered. Reference claim 16 recites the formulation is a liquid aqueous solution. Reference claims 3-4 recite the concentration of 2-deoxy-D-glucose in the formulation is 0.1 mM - 500 mM or 0.25 mM - 250 mM, corresponding to limitations of claims 16 and 22. Reference claim 5 recites the formulation comprises at least one excipient or at least one additional active agent. Reference claim 6 recites the 2-deoxy-D-glucose is administered at a dose of 0.01 μmol-50 μmol. Reference claim 12 recites the formulation is administered into a nostril of the individual.
Reference claims 1-12 do not specifically recite a formulation as a nasal spray (claims 16 and 23).
Yao et al. teaches as above. Yao et al. teaches formulating a formulation comprising 2 deoxy-D-glucose administered intranasally as a spray, excipients thereof, and formulating sterile pharmaceutical compositions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-12 in view of Yao et al. in order to formulate the composition of the method of the Reference claims as a nasal spray. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Yao et al. with a reasonable expectation of success because both the Reference claims and Yao et al. teach formulations comprising 2-deoxy-D-glucose administered intranasally, and Yao et al. teaches known excipients thereof and known methods of formulating the composition as detailed above.
The current record as detailed in the Application Data Sheet (ADS) filed 07 March 2024 lists the examined application related as a Continuation application of 16/770,482 which was issued as US 11,413,298. MPEP 804.01 provides “The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that “the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.”” Therefore, while a restriction requirement was made in 16/770,482, the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply because the ADS filed 07 March 2024 currently indicates the examined application related as a Continuation application rather than a Divisional application.
Claims 16, 21-22, 24-27, and 32-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,011,453 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because Reference claims 1-19 of the reference patent are drawn to a method comprising obtaining a pharmaceutically acceptable formulation comprising 2 deoxy-D-glucose and spraying an amount of the formulation into one or both nostrils of a human, making obvious possession of the nasal spray formulation so administered. Reference claim 4 recites the formulation is a liquid aqueous solution. Reference claims 1 and 5 recite the concentration of 2-deoxy-D-glucose in the formulation is 0.1 mM - 500 mM or 0.25 mM - 250 mM, corresponding to limitations of claims 16 and 24, and 22 and 33, respectively. Reference claims 10-12 recite the 2-deoxy-D-glucose as the single active agent, addressing limitations of claim 16. Reference claims 6-9 recite the 2-deoxy-D-glucose in combination with decongestants or NSAIDS, addressing limitations of claim 24-27. Reference claim 13 recites the 2-deoxy-D-glucose is administered at a dose of 0.01 μmol-50 μmol.
Further, regarding claims 21 and 32, Reference claims 1-19 do not specifically recite the dose of at least 25 μmol.
It would have been obvious to one of ordinary skill in the art to select from within the scope of the reference claims in order to select the dose of the formulation. One of ordinary skill in the art would have been motivated to modify the reference claims with a reasonable expectation of success because Reference claim 13 recites the 2-deoxy-D-glucose is administered at a dose of 0.01 μmol-50 μmol, which overlaps in scope with the dose of at least 25 μmol, and suggests selecting the effective amount through routine experimentation. See MPEP 2144.05 at I. providing “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)” and at II.A. providing “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical.”
The current record as detailed in the Application Data Sheet (ADS) filed 07 March 2024 lists the examined application related as a Continuation application of 17/811,488 which was issued as US 12,011,453. MPEP 804.01 provides “The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that “the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.”” Therefore, while a restriction requirement was made in parent case 16/770,482, the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply because the ADS filed 07 March 2024 currently indicates the examined application related as a Continuation application rather than a Divisional application.
Claims 16-33 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,011,453 (reference patent) in view of Yao et al. (US 2012/0238511, published 20 Sep 2012, cited in PTO-892).
Reference claims 1-19 of the reference patent teach as above.
Reference claims 1-19 do not specifically recite the excipients of the formulation or the formulation being sterile (claims 17-20, 23, and 28-31).
Yao et al. teaches as above. Yao et al. teaches formulating a formulation comprising 2 deoxy-D-glucose administered intranasally as a spray, excipients thereof, and formulating sterile pharmaceutical compositions.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-19 in view of Yao et al. in order to formulate the composition of the method of the Reference claims as a nasal spray. One of ordinary skill in the art would have been motivated to combine the Reference claims in view of Yao et al. with a reasonable expectation of success because both the Reference claims and Yao et al. teach formulations comprising 2-deoxy-D-glucose administered intranasally, and Yao et al. teaches known excipients thereof and known methods of formulating the composition as detailed above.
The current record as detailed in the Application Data Sheet (ADS) filed 07 March 2024 lists the examined application related as a Continuation application of 17/811,488 which was issued as US 12,011,453. MPEP 804.01 provides “The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that “the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.”” Therefore, while a restriction requirement was made in parent case 16/770,482, the prohibition against nonstatutory double patenting rejections under 35 U.S.C. 121 does not apply because the ADS filed 07 March 2024 currently indicates the examined application related as a Continuation application rather than a Divisional application.
Conclusion
No claim is currently in condition for allowance.
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/JONATHAN S LAU/ Primary Examiner, Art Unit 1693