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
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I: Compositions- claims 1-9 and 25-30,
Group II: Dispensers- claims 10-14 (now cancelled)
Group III: Methods of treating neurological diseases- claims 15-16
Group IV: Methods for the treatment of a microbial infection- 17, 18 and 23,
Group V: Methods of killing a microorganism- claims 19-22.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
The technical feature linking the claims is the compound which is not a contribution over the art as evidenced by the following prior art rejections.
Therefore, the technical feature linking the claims does not constitute a special technical feature under PCT Rule 13.2. Accordingly, the claims lack unity of invention, and restriction is proper.
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
As provided in 37 CFR 1.475(b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475(c).
The examiner contacted Raymond Smith on 2/9/26 to request a telephone election. Applicant's election without traverse of Group I, claims 1-9 and 25-30, in the filing dated 2/9/2026 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 25-30 are rejected under 35 U.S.C. 112(b) 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.
Claim 1 has the language “essentially absent of additional antimicrobial preservatives” which is unclear as to the metes and bounds of both “essentially absent” and “additional”. Regarding “essentially absent” the specification does not define the scope and one of skill in the art would not know how to evaluate what amount of preservative is allowed due to the lack of any guidance or examples in the specification. MPEP 2173.05(b). One of skill in the art would not know whether the scope of the claims allows small amounts of preservative, and if so, what amount is small, or alternatively no preservative is allowed. The claim language of “additional” further confuses the scope of the claim, because it implies the “composition comprising a compound” has preservatives present. Thus, the claim and those that depend therefrom are rejected as indefinite.
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:
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,
also known as “memogain”.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-9, 25-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maelicke (WO2014016430).
Maelicke teaches GLN-1062 including in a pharmaceutical composition which is the same compound as Alpha-1062 (Claims 3, 29, and 32; Example 4). Maelicke teaches the compound is in solution at 10% w/v (claim 32 – equivalent to 100mg/mL) which anticipates claims 1-6. 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).
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 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 1-9, 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Maelicke (WO2014016430).
Maelicke teaches as detailed above in the 35 USC 102 rejection of claims 1-9, 25-27 supra and incorporated herein. Maelicke also renders these claims obvious. "[A] disclosure that anticipates under § 102 also renders the claim invalid under § 103, for `anticipation is the epitome of obviousness.'" Connell v. Sears, Roebuck & Co., 722 F.2d 1542, 1548, 220 USPQ 193, 198 (Fed.Cir.1983) (citing In re Fracalossi, 681 F.2d 792, 215 USPQ 569 (CCPA 1982)).
Regarding claim 28-30 specifying volumes of the dose and the container, Maelicke teaches 50 mL intranasal dose (claim 32, p. 12) and doses of 40mg/day, 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).
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.
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 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.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626