DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ claimed invention, filed 1 July 2024, in the matter of Application N° 18/760,513. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application is being examined under the pre-AIA first to invent provisions.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, claims 1-16 represent all claims currently under consideration.
Information Disclosure Statement
Two Information Disclosure Statements (IDS) filed 17 September 2024 and 1 October 2024 are acknowledged and have been considered.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
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 1-16 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.
Claim 1 is rendered indefinite because of the limitation reciting “and a pharmaceutically acceptable carrier or diluent”. It is unclear whether “carrier” and “diluent” are alternative, synonymous terms, or if they are meant to embody two different groups of compounds. Discussion of the term “pharmaceutically acceptable carrier” in the instant specification appears to always be paired with “diluent” in the alternative. However, other uses of the term “diluent” in the specification and then later in the claims appear to imply that “diluent” is a species of excipient.
Claims 2-16 are rendered indefinite as they depend from or require the limitations of claim 1.
Claim 3 recites the limitation “…and optional excipients” in lines 2-3 of the claim. There is insufficient antecedent basis for this limitation in the claim since the claim from which it depends, recites the component as being “optionally one or more other excipients”.
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 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of Marshall et al. (USPN 12,064,439 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claims 15 and 16 are directed to a pharmaceutical composition obtained by the process of claim 1 and claim 2, respectively.
Reference claim 1 discloses:
A dosage unit comprising 20 to 300 mg of a compound of the following formula:
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or comprising 20 to 300 mg of a free base equivalent of said compound, and further comprising a pharmaceutically acceptable carrier, diluent, or excipient.
The limitations of the instant claims are directed to compositions and not the methods by which they are produced. See MPEP §2113.
As such, were the reference patent available as prior art, it would anticipate the instantly claimed compositions.
Claims 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of Marshall et al. (USPN 10,864,216 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of claims 15 and 16 are discussed above as being directed to a pharmaceutical composition.
Reference claim 1 discloses:
A method of treating a disease selected from the group consisting of: skin cancer or melanoma; a viral disease; a bacterial disease; and a protozoal disease, the method comprising administering to a subject in need thereof the compound of the following formula:
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or a pharmaceutically acceptable salt, solvate, or hydrate thereof.
Reference claim 2 discloses:
The method of claim 1, wherein the administering is oral.
Were the reference patent available as prior art, it would anticipate the instantly claimed compositions particularly as the method discloses administering an orally formulated version (i.e., dosage form) of the compound disclosed in claim 1. That is, the administered composition is considered to stand apart from the compound itself.
Claims 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of Marshall et al. (USPN 9,907,804 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of claims 15 and 16 are discussed above as being directed to a pharmaceutical composition.
Reference claim 1 discloses:
A method of treating a disease of protein aggregation comprising administering to a subject in need thereof the compound of the following formula:
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or a pharmaceutically acceptable salt, solvate, or hydrate thereof, wherein the protein is selected from TDP-43, Huntingtin, and α-synuclein.
Reference claim 2 discloses:
The method of claim 1, wherein the administering is oral.
Were the reference patent available as prior art, it would anticipate the instantly claimed compositions particularly as the method discloses administering an orally formulated version (i.e., dosage form) of the compound disclosed in claim 1. That is, the administered composition is considered to stand apart from the compound itself.
Claims 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-8 of Wischik et al. (USPN 12,128,051 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of claims 15 and 16 are discussed above as being directed to a pharmaceutical composition.
Reference claim 1 discloses:
A method of therapeutic treatment of a neurodegenerative disorder of protein aggregation in a subject,
which method comprises orally administering two or more times per day to said subject a methylthioninium (MT)-containing compound,
wherein said administration provides a total daily dose of between 0.5 and 20 mg of MT to the subject per day,
wherein the MT-containing compound is a compound of the following formula (“LMTX”):
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wherein each of HnA and HnB (where present) are protic acids which may be the same or different.
Reference claims 6-8 narrow the scope of the protic acids used in defining p(HnA) and q(HnB) to methanesulfonic acid, such that the compound of the administered dosage for is “LMTM” in claim 8:
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Were the reference patent available as prior art, it would anticipate the instantly claimed compositions particularly as the method discloses administering an orally formulated version (i.e., dosage form) of the compound disclosed in claim 1. That is, the administered composition is considered to stand apart from the compound itself.
Claims 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Wischik et al. (USPN 11,759,469 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations of claims 15 and 16 are discussed above as being directed to a pharmaceutical composition.
Reference claim 1 discloses:
A method of therapeutic treatment of mild cognitive impairment 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 and 20 mg of MT to the subject per day,
wherein the MT-containing compound is LMTM:
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Were the reference patent available as prior art, it would anticipate the instantly claimed compositions particularly as the method discloses administering an orally formulated version (i.e., dosage form) of the compound disclosed in claim 1. That is, the administered composition is considered to stand apart from the compound itself.
Claims 1, 15, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 of Wischik et al. (USPN 11,065,256 B2). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations recited by instant claims 15 and 16 are discussed above. The limitations of instant claim 1 recite a method of preparing a pharmaceutical composition comprising admixing a compound having the following formula:
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and a pharmaceutically acceptable carrier or diluent.
Reference claims 16-18 are directed to a tablet or capsule dosage form containing the following compound:
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Were the reference patent available as prior art, it would anticipate the instantly claimed compositions. Furthermore, the claim is considered to render the instantly claimed method prima facie obvious owing to its required combination with any additional component (i.e., carrier, excipient, etc.) in order to form a tablet or capsule.
Claims 15 and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 51-53 of copending Application No. 19/063,699 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
The limitations recited by instant claims 15 and 16 are discussed above.
Reference claim 1 discloses:
A method of therapeutic treatment of a neurodegenerative disorder of protein aggregation in a human subject,
which method comprises orally administering to said subject a methylthioninium (MT)-containing compound,
wherein said administration provides a total daily oral dose of between 20.5 and 60 mg of MT to the subject per day, optionally split into 2 or more doses,
wherein the MT-containing compound has the following formula:
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wherein each of HnA and HnB (where present) are protic acids which may be the same or different.
Reference claims 51-53 narrow the above compound to the instantly administered compound.
Were the reference patent available as prior art, it would anticipate the instantly claimed compositions particularly as the method discloses administering an orally formulated version (i.e., dosage form) of the compound disclosed in claim 1. That is, the administered composition is considered to stand apart from the compound itself.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4, 6, 9-12, 15, and 16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 10-12, 14, 18, 28, and 39 of copending Application No. 19/113,777 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other.
Instant claim 1 recites:
A process for preparing a pharmaceutical composition comprising admixing a compound of the following formula:
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and a pharmaceutically acceptable carrier or diluent.
Instant claim 2 recites:
The process according to claim 1, which process comprises dry compression of an intimate powder mixture comprising the compound with at least one diluent suitable for dry compression and optionally one or more other excipients.
Instant claim 3 recites:
The process according to claim 2, wherein the process comprises a direct compression process wherein said compound, at least one diluent, and optional excipients are blended together in solid particulate form to create said intimate mixture and then compressed using a tablet machine.
Instant claims 4 and 6 further define the excipients used in preparing the tablets.
Instant claim 9 recites:
The process according to claim 2, wherein the process comprises a dry granulation process wherein said compound, at least one diluent, and optional excipients are formed into a compressed mass, milled, and then compressed using a tablet machine.
Instant claims 10-12 each recite applying a film coating to the resulting tablets.
Reference claim 18 discloses:
A process for the manufacture of the pharmaceutical composition according to any one of claim 14, which process comprises: (i) compression or granulation of the DAPTZ compound with the one or more other accompanying active ingredients, additives, excipients, diluents, binders, lubricants, disintegrants, fillers, stabilizers, surfactants, antioxidants, if present; (ii) applying the film coating to the tablets, optionally wherein the step of applying a film coating is carried out by spray-coating the tablet core in a coating machine, wherein the coating machine and cores are optionally pre-heated to 42-52°C, and adjusting temperature of inlet air so the exhaust temperature is maintained between 42-52°C.
The composition disclosed in claim 18, further states that the compound used is disclosed in reference claim 14. Reference claim 14 is further defined in reference claims 38 and 39 as follows:
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Were the reference available as prior art, the Examiner submits that the disclosed method of preparation would minimally render the instantly claimed method prima facie obvious, where it did not anticipate it.
Furthermore, the disclosed compositions and compositions resulting from the method claims would also be considered to anticipate the instant compositions recited by claims 15 and 16.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter
Claims 1-16 appear to be free of the prior art.
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615
Prosecution Insights