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 .
Priority
This application is a 371 of PCT/CA2021/050666 (05/14/2021).
Election/Restrictions
Applicant previously elected without traverse of the composition of Group I, claims 1-9 and 25-30, in the filing dated 2/9/2026.
Status
Rejections not reiterated are withdrawn.
Claims 1, 3, 5-9, 15-23, 26, and 27 are pending. Claims 15-23 are withdrawn.
Claim Interpretation
The claim language “compound Alpha-1062” is interpreted as defined in the specification as: “The galantamine pro-drug Alpha-1062, is a benzoic ester of galantamine ((4aS,6R,8aS)- 5,6,9,10,11,12-hexahydro-3-methoxy-11-methyl-4aH-[1]benzofuro[3a,3,2-ef][2]benzazepin-6-ol benzoate)”, with the following structure:
PNG
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also known as “memogain”.
Claim Rejections - 35 USC § 112
Claims 3, 5-7 are rejected under 35 U.S.C. 112(b) and (d) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention and failing to depend form from a claim previously set forth and then specify a further limitation of the subject matter claimed.
Claim 3 depends from claim 2 which is cancelled and thus lacks a proper antecedent basis and/or an improper dependent claim as per MPEP 608.01(n) and 35 USC 112(d) and is accordingly rejected.
Claim 5 depends from claim 4 which is cancelled and thus lacks a proper antecedent basis and/or an improper dependent claim as per MPEP 608.01(n) and 35 USC 112(d) and is accordingly rejected. Similarly, claims 6-7 which depend from claim 5 are also rejected.
Claim Rejections - 35 USC § 103
Claims 1, 3, 5-9, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Maelicke (WO2014016430).
Maelicke teaches GLN-1062 including in a pharmaceutical composition which is the same compound as Alpha-1062 (Claim 3; claim 22:” salt of GLN 1062, which is administered intranasally as a 2 to 40% weight per volume (w/v) solution at an amount of 20 to 100 microliters in a single intranasal spray event”; claim 23: “salt of GLN 1062, which is administered intranasally as a 10% weight per volume (w/v) solution at an amount of 50 microliters in a single intranasal spray event”). Maelicke teaches the compound is in solution at 10% w/v (claim 23 – equivalent to 100mg/mL).
Regarding claim 1’s negative limitation language of “the composition is absent of additional antimicrobial preservatives”, the prior art need not state the absence of the limitation. Almirall, LLC v. Amneal Pharm., 28 F.4th 265, 273 (Fed. Cir. 2022) (“"[A] reference need not state a feature's absence in order to disclose a negative limitation." AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019).”).
Regarding claim 1’s language specifying volumes of the dose and the container, Maelicke teaches 50 mL intranasal dose (claim 23) and doses of 40mg/day (p. 10), but does not specify the total volume of liquid composition of 2 to 50 mL.
One of ordinary skill in the art of pharmaceutical formulation following the teaching of Maelicke would have considered selecting a dispenser that would be capable of administering the 40mg/day dose which when using the 10% w/v is 100 mg/mL and combined with 50 mL intranasal spray would provide 5 mg/spray (100mg/mL x 0.050 mL = 5 mg). Thus, one of ordinary skill in the art would have considered including enough volume to at least meet a week of daily doses and include at least 2.8 mL in the dispenser (40/5 = 8 doses/day * 0.050 mL/dose => 0.4 mL/day * 7 days => 2.8 mL) to find the optimum or workable range by routine experimentation or simple calculation and arrive at the claimed invention with a reasonable expectation of success.
Regarding claim 3, Maelicke teaches the composition is in solution as per above. Regarding claim 5, Maelicke teaches a concentration of 100 mg/mL as detailed above. Regarding claim 6, Maelicke teaches gluconate salt (claims 22-23).
Regarding claim 7, Maelicke teaches the compound is at 5 to 15% (w/v) (claim 31) which in view of the embodiment of 10% one of skill in the art would at once envisage 9% and arrive at the claimed invention. MPEP 2131.02-III. Regarding claims 8-9 specifying CFU effectiveness, according to the specification on page 32, 82mg/mL of the compound was required, thus Maelicke’s teaching of 10% w/v anticipates.
Regarding claims 25-26 specifying a multi-use dispenser for intranasal administration, Maelicke teaches intranasal administration by a sprayer metered dose device (p. 12, lines 23-28). Regarding claim 27 specifying oral cavity administration, Maelicke teaches the same (p. 12 line 29 – p. 13).
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine formulating the pharmaceutical composition using a dispenser based on the teaching of the art. One of ordinary skill in the art would have considered providing a dispenser as required in such a formulation, such configurations are well-known and routinely used in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Response to Remarks - 35 USC § 103
Applicant argues that Maelicke does not teach the claimed “composition comprising a compound Alpha-1062 or salt thereof, wherein the composition is absent of additional antimicrobial preservatives”.
This argument is not persuasive because Maelicke teaches a pharmaceutical composition comprising the same compound, Alpha-1062 (Claims 3, 22-23), without specifying the presence of additional antimicrobial preservatives. The prior art need not state the absence of the limitation. Almirall, LLC v. Amneal Pharm., 28 F.4th 265, 273 (Fed. Cir. 2022) (“"[A] reference need not state a feature's absence in order to disclose a negative limitation." AC Techs., S.A. v. Amazon.com, Inc., 912 F.3d 1358, 1367 (Fed. Cir. 2019).”). In addition, one of ordinary skill in the art following the teaching of Maelicke would have considered optimization of the formulation and performed routine experimentation in view of the absence of the teaching of the need for additional preservatives and arrive at the claimed invention with a reasonable expectation of success.
Applicant alleges that “The antimicrobial properties of Alpha-1062 were entirely unexpected are not taught or suggested in the prior art,” however, Applicant’s statement does not meet their burden to establish how the alleged result is in fact unexpected and of both statistical and practical significance. MPEP 716.02.
Double Patenting
Claims 1-9, 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12208167 in view of Maelicke (WO2014016430). The patent claims a composition comprising the same compound and as detailed in the prior art rejections above the instant invention is rendered obvious.
Claims 1-9, 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12157743 in view of Maelicke (WO2014016430). The patent claims a composition comprising the same compound and as detailed in the prior art rejections above the instant invention is rendered obvious.
Claims 1-9, 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11795176 in view of Maelicke (WO2014016430). The patent claims a composition comprising the same compound and as detailed in the prior art rejections above the instant invention is rendered obvious.
Claims 1-9, 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of copending Application No. 18965776 (reference application) in view of Maelicke (WO2014016430). The reference application claims a composition comprising the same compound and as detailed in the prior art rejections above the instant invention is rendered obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 19036739 (reference application) in view of Maelicke (WO2014016430). The reference application claims a composition comprising the same compound and as detailed in the prior art rejections above the instant invention is rendered obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-9, 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 19247344 (reference application) in view of Maelicke (WO2014016430). The reference application claims a composition comprising the same compound and as detailed in the prior art rejections above the instant invention is rendered obvious. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks - Double Patenting
Applicant argues in the same manner as in the 35 USC 103 rejection above. This argument is not persuasive for the same reasons as above.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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