DETIALED 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 .
Status of Claims
Claims 1-5, 10-11, 19, 22, 26, 32, 36-39, 45-46, 48-50, 53 and 55-56 are pending in the instant application. Claims 1, 3-5, 10-11, 19, 22, 26, 32, 36-39, 45-46, 48-50, 53 and 55-56 are amendment and claims 6-9, 12-18, 20-21, 23-25, 27-31, 33-35, 40-44, 47, 51-52, 54 and 57-68 are cancelled via the amendment filed January 16th, 2026.
Priority
This is a 35 U.S.C. 371 National Stage filing of International Application No. PCT/EP2023/064369 filed May 30th, 2023, which claims priority under 35 U.S.C. 119(a-d) to GB2214646.8, filed October 5th, 2022 and GB2208038.6, filed May 31st , 2022. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed January 16th, 2026 was considered by the Examiner.
Claim Rejections - 35 USC § 112(b)
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 1-5, 19, 22, 26, 32, 36-39, 48-50, 53 and 55-56 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term "preferably" in claims 1 and 5 is a relative term which renders the claim indefinite. The term "preferably" is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As drafted, "preferably" within claims 1 and 5 renders the metes and bounds of claims 1 and 5 undefined (hence rendering claims 1 and 5 indefinite) since the artisan has no idea what standard constitutes "preferably" Furthermore, the limitation "preferably" can also be construed as rendering claims 1 and 5 indefinite since the artisan does not know whether the limitations following "preferably" are required limitations of the claim or are merely exemplary embodiments.
Claims 2-5, 19, 22, 26, 32, 36-39, 48-50, 53 and 55-56 depended from claim 1 and do not resolve the issue of indefiniteness and, as such, are also indefinite.
Claims 53 and 55-56 recites the limitation "the disorder". There is insufficient antecedent basis for this limitation in the claim. It is recommended that Applicant amend the claim to replace “the disorder” with “the disease”.
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.
Claim(s) 1-5, 10-11, 19, 22, 26, 32, 36-39, 45-46, 48-50, 53 and 55-56 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wischik et al (WO 2018/019823 A1, published February 1st, 2018, as cited on the IDS).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Wischik teaches a method of therapeutic treatment of a neurodegenerative disorder in a subject, which method comprises orally administering to said subject a methylthioninium (MT)- containing compound, wherein said administration provides a total daily dose of between 0.5 mg and 20 mg of MT to the subject (claim 1). Wischik also teaches that the duration of treatment with the MT compound is at least 7 months or longer (claim 36).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Wischik does not explicitly teach that the administration is at a dosage frequency of less than once daily.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
However, Wischik teaches that the administration of the MT compound is daily to provide a total daily dose of between 0.5 and 20 mg. The daily dose taught by Wischik falls within the instantly claimed scope. Further, Wischik teaches that much lower doses of MT than previously envisaged can produce substantial clinical benefits whilst being well tolerated and having fewer side effects than the higher doses (page 6).
Also, one of ordinary skill in the art would have been motivated to alter the dosage routine as taught by Wischik in order to optimize the method to provide the most effective treatment. See MPEP 2144.05: 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. "[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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)(Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
Thus, regarding claim 1, as Wischik teaches a method of treating a neurodegenerative disorder with an MT-containing compound in the instantly claimed daily dosage range, one of ordinary skill in the art would have been motivated to optimize these teachings and administer the compound in a dosage frequency that is not daily as a routine optimization, especially being that Wischik teaches that lower dosage of the compound lead to a more effective treatment. Also, instant claims 2-5 and 46, further place limitation on the dosage frequency and are also rendered obvious for the same reasons.
Regarding claims 10-11, as seen above, Wischik teaches that the administration provides a total daily dose of between 0.5 mg and 20 mg of MT to the subject.
Regarding claim 19, Wischik teaches that the MT-containing compound is (claim 8):
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Regarding claim 22, Wischik teaches that the MT-containing compound is (claim 11):
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Regarding claim 26, Wischik teaches that the MT-containing compound is (claim 15):
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Regarding claim 32, Wischik teaches that the MT-containing compound is (claim 21):
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Regarding claim 36, Wischik teaches that the MT-containing compound is (claim 25):
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Regarding claim 37, Wischik teaches that the MT-containing compound is MTC (claim 26).
Regarding claim 38, Wischik teaches that the compound is MTC polymorph pentahydrate (claim 27).
Regarding claim 39, Wischik teaches wherein the compound is characterized by a purity of greater than 98% (claim 28).
Regarding claim 45, Wischik teaches wherein the total daily dose of MTC.5H2O is around 0.7 to 29 mg/day, more preferably around 5 to 10 mg/day (claim 33).
Regarding claim 48, Wischik teaches wherein the MT+ salt is formulated with a reducing agent which is optionally ascorbate, and then optionally lyophilized (claim 34).
Regarding claim 49, as seen above, Wischik teaches that the treatment is at least 7 months.
Regarding claim 50, Wischik teaches wherein the subject is a human who has been diagnosed as having said cognitive or CNS disorder, or wherein said method comprises making said diagnosis (claim 36).
Regarding claim 53, Wischik teaches the disorder is a tauopathy (claim 44).
Regarding claim 55, Wischik teaches that the disorder is Alzheimer's disease (claim 46).
Regarding claim 56, Wischik teaches the disorder is mild cognitive impairment(claim 56).
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 1-5, 10-11, 19, 22, 26, 32, 36-39, 45-46, 48-50, 53 and 55-56 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. 9,242,946 B2, in view of Wischik et al (WO 2018/019823 A1, published February 1st, 2018, as cited on the IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims a method of treatment of a patient with a tauopathy comprising administering to said patient a therapeutically effective amount of a high purity diaminophenothiazinium compound according to claim 1 (claim 1). The compound of claim 1 is
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. As the patent is drawn to a method of treating a tauopathy with a MT-containing compounds, the claims are obvious variants for the same reasons as listed in the 35 U.S.C. 103 rejection.
Claims 1-5, 10-11, 19, 22, 26, 32, 36-39, 45-46, 48-50, 53 and 55-56 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,065,256 B2, in view of Wischik et al (WO 2018/019823 A1, published February 1st, 2018, as cited on the IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The patent claims:
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As the patent is drawn to a method of treating a neurodegenerative disorder with a MT-containing compounds, the claims are obvious variants for the same reasons as listed in the 35 U.S.C. 103 rejection.
Conclusion
No claim is allowed.
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/A.G.K./Examiner, Art Unit 1626
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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