DETAILED ACTION
This office action is in response to applicant’s filing dated February 18, 2025.
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of Claims
Claims 27-46 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed February 18, 2025. Acknowledgement is made of Applicant's cancelation of claims 1-26; and addition of new claims 27-46.
Claims 27-46 are presently under examination.
Priority
The present application is CON of US Application No. 17/745,024 filed on May 16, 2022, which is a DIV of US Application No. 15/656,062 filed on July 21, 2017, which is a DIV of US Application No. 13/810,772 filed on June 24, 2013, which is a 371 of PCT/US2011/044697 filed on July 20, 2011 which claims benefit of U.S. Provisional Application No. 61/366,075 filed on July 20, 2010.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on March 3, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
In the instant case, the abstract contains a phrase which can be implied, “Disclosed herein are.”
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
In the instant case, the abstract does not disclose the general nature of the compound.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 27-46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yamabe et al (US 2003/0212094 A1, cited in the IDS filed March 3, 2025).
Regarding claims 27, 28, 37, 38, and 42, Yamabe teaches a medicament comprising 2-((1-(2-(4-fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)isoindolin-1-one, which is equivalent to the compound of instant claims 28 and 42, hereinafter referred to as Compound A (claims 12 and 18):
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and a medicament comprising 4-fluoro-2((1-(2-(4-fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)-isoindolin-1-one, which is equivalent to the compound of instant claim 29, hereinafter referred to as Compound B (claims 13 and 18):
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4-fluoro-2((1-(2-(4-fluorophenyl)-2-oxoethyl)piperidin-4-yl)methyl)-isoindolin-1-one
which are used for a disease that can be therapeutically treated by the nerve controlling function of a sigma ligand including schizophrenia (claims 19 and 20). Yamabe teaches the methods for therapeutically treating diseases by the nerve controlling function of sigma ligands comprise the step of administering to a mammal including a human an effective amount of a sigma ligand compound salt, hydrate or solvate thereof [0026]. Thus, Yamabe teaches a method of treating schizophrenia comprising administering an effective amount of Compound A or Compound B.
The prior art is silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method taught by the prior art: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Regarding the claimed amounts and dosing regimen of a compound of formula (I), Compound A, of instant claims 27, 30-36, and 42-46, Yamabe teaches the doses of the medicament of the present invention should be suitably determined depending on a type of a disease to be treated, purpose of preventive or therapeutic treatment, the age, body weight and conditions of a patient and the like; a dose for adult patient per day may generally be within the range of about from 0.05 to 500 mg for oral administration; and in general, the aforementioned dose may be administered once or two or more divided portions in a day [0095].
MPEP 2144.05 states: 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Regarding claims 38-41, the wherein limitations of these claims, are considered to simply express the intended result of a process step positively recited, which is not given patentable weight (See MPEP 2111.04: [T]he court noted (quoting Minton v. Nat'lAss'n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQgd 1614, 1690 (Fed. Cir. 2003)) that a "'whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.'" Hoffer v. Microsoft Corp., 405 F.3d 1396, 1399, 74 USPQgd 1481, 1483 (Fed. Cir. 2005).).
Taken together, all this would result in the practice of the method of claims 27-46 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 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 9,732,059. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating at least one negative symptom of schizophrenia in a human subject comprising administering to a human subject in need thereof a compound of formula (II), wherein said compound is administered at a dose of between 0.1 mg and 128 mg including between 1 mg and 64 mg, wherein the compound is administered between once daily and four times daily including twice daily, and wherein a negative symptom includes difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking. The compound of formula (II) anticipates the compounds of instantly claimed formula (I) and is equivalent to the instantly claimed compound of claim 28 and 42.
Thus, the method of the previously allowed claims would anticipate the instantly claimed method.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 9,458,130 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating a neuropsychiatric disease comprising administering a Compound of formula (I) (claims 1 and 8) wherein the neuropsychiatric disorder is schizophrenia. The compound of the previously allowed claims is equivalent to the instant claimed compound of claims 28 and 42 and thus anticipates the compounds of instantly claimed formula (I).
The previously allowed claims are silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method of the previously allowed claims: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the method of the previously allowed claims would anticipate the instantly claimed method.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,730,920 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating at least one negative symptom of schizophrenia in a subject in need thereof comprising administering to the subject between 10-75 mg of Compound (I). The compound of formula (II) anticipates the compounds of instantly claimed formula (I) and is equivalent to the instantly claimed compound of claim 28 and 42.
The previously allowed claims are silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method of the previously allowed claims: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the method of the previously allowed claims would anticipate the instantly claimed method.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 10,258,614 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating at least one symptom of schizophrenia in a human subject in need thereof comprising administering to the subject once daily a pharmaceutical formulation in a sustained-release form comprising 10-75 mg of Compound (I), wherein the symptom of schizophrenia is cognitive impairment. Compound (I) is equivalent to the instantly claimed compound of claim 28 and 42 and anticipates the compounds of instantly claimed formula (I).
Thus, the method of the previously allowed claims would anticipate the instantly claimed method.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,799,493 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a pharmaceutical formulation comprising a release modifier and between about 1 mg and about 100 mg of Compound (I). Compound (I) is equivalent to the instantly claimed compound of claims 28 and 42 and anticipates the compounds of instantly claimed formula (I). The specification of the previously allowed patent teaches the compositions are useful for treating schizophrenia (title); and in one embodiment the formulations are administered for treating at least one symptom of schizophrenia is cognitive function (Col 11, lines 20-24).
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
Claims 27-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,464,744 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating negative symptoms in a subject comprising administering to the subject a gastro-resistant controlled release dosage form comprising 1H-isoindol-1-one, 2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-, hydrochloride, hydrate (1:1:2) (roluperidone hydrochloride) wherein the subject has a diagnosis of schizophrenia. Roluperidone hydrochloride is a pharmaceutically acceptable salt of the compound having the structure of instantly claimed compound of claim 28 and 42 and anticipates the compounds of instantly claimed formula (I).
The previously allowed claims are silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method of the previously allowed claims: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the method of the previously allowed claims would anticipate the instantly claimed method.
Claims 4-6, 9, and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,048,768 B2 in view of Yamabe et al (US 2003/0212094 A1, cited in the IDS filed March 3, 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The previously allowed claims are directed to a method of treating negative symptoms in a subject comprising administering to the subject a gastro-resistant controlled release dosage form comprising 1H-isoindol-1-one, 2-[[1-[2-(4-fluorophenyl)-2-oxoethyl]-4-piperidinyl]methyl]-2,3-dihydro-, hydrochloride, hydrate (1:1:2) (roluperidone hydrochloride) wherein the subject has a diagnosis of schizophrenia. Roluperidone hydrochloride is a pharmaceutically acceptable salt of the compound having the structure of instantly claimed compound of claims 28 and 42 and anticipates the compounds of instantly claimed formula (I). The previously allowed claims do not explicitly teach the claimed amounts or dosing regimen.
However, Yamabe teaches the doses of the medicament of the present invention should be suitably determined depending on a type of a disease to be treated, purpose of preventive or therapeutic treatment, the age, body weight and conditions of a patient and the like; a dose for adult patient per day may generally be within the range of about from 0.05 to 500 mg for oral administration; and in general, the aforementioned dose may be administered once or two or more divided portions in a day [0095].
MPEP 2144.05 states: 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
The previously allowed claims are silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will naturally flow from the teachings of the previously allowed claims (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method of the previously allowed claims: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the method of the instant claims from the method of the previously allowed claims in view of Yamabe.
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 8-11, 13, 14, 18-22, 24-29, 31, and 36-38 of copending Application No. 18/168,028 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims are directed to a method of preventing relapse in a schizophrenia patient comprising administering a therapeutically effective amount of roluperidone to the schizophrenia patient wherein the schizophrenia patient has negative symptoms wherein the therapeutically effective amount is about 32 mg or about 64 mg. Roluperidone is a compound having the structure of instantly claimed compound of claims 28 and 42 and anticipates the compounds of instantly claimed formula (I).
The copending claims are silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method of the copending claims: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the method of the copending claims would anticipate the instantly claimed method.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 15-23, 37, 38, 54-60 of copending Application No. 18/738,782 (reference application) in view of Yamabe et al (US 2003/0212094 A1, cited in the IDS filed March 3, 2025). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims are directed to a method of treating negative symptoms in a subject, wherein the patient has a diagnosis of schizophrenia comprising administering a therapeutically effective amount of Compound (I) to the schizophrenia patient wherein the schizophrenia patient has negative symptoms wherein the therapeutically effective amount is about 32 mg or about 64 mg. Compound (I) is a compound having the structure of instantly claimed compound of claims 28 and 42 and anticipates the compounds of instantly claimed formula (I).
The copending claims do not explicitly teach the claimed amounts or dosing regimen.
However, Yamabe teaches the doses of the medicament of the present invention should be suitably determined depending on a type of a disease to be treated, purpose of preventive or therapeutic treatment, the age, body weight and conditions of a patient and the like; a dose for adult patient per day may generally be within the range of about from 0.05 to 500 mg for oral administration; and in general, the aforementioned dose may be administered once or two or more divided portions in a day [0095].
MPEP 2144.05 states: 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). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
The copending claims are silent regarding “treating or improving cognition.” However: “treating or improving cognition in a subject suffering from schizophrenia” will naturally flow from the teachings of the previously allowed claims (see above rejection), since the same compound (Compound A, a compound of formula (I)) is being administered to the same subjects (a subject suffering from schizophrenia). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating or improving cognition in a subject suffering from schizophrenia,” by practicing the method made obvious by the prior art: “the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia,” one will also be “treating or improving cognition in a subject suffering from schizophrenia” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating or improving cognition in a subject suffering from schizophrenia”) of the method taught by the prior art (“the administration of Compound A, a compound of formula (I), to a patient suffering from schizophrenia”).
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Thus, it would have been prima facie obvious to one of ordinary skill in the art to arrive at the method of the instant claims from the method of the copending claims in view of Yamabe.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 15-23, 37, 38, 54-60 of copending Application No. 18/961,748 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims are directed to a pharmaceutical formulation comprising a release modifier and 64 mg of Compound (I). Compound (I) is a compound having the structure of instantly claimed compound of claims 28 and 42 and anticipates the compounds of instantly claimed formula (I). Moreover, the specification of the copending application teaches the formulations of the disclosure are administered for treating at least one symptom of schizophrenia including cognitive function [00119].
In Sun Pharmaceutical Industries Ltd. v. Eli Lilly and Co., 95 USPQ2d 1797 (Fed. Cir. 2010), the Court determined that Claims of a later patent were held invalid for obviousness-type double patenting when the earlier patent claimed a compound and disclosed its utility in specification, and later patent claimed a method of using compound for use described in specification of earlier patent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 27-46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 13-22 of copending Application No. 19/021,774 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The copending claims are directed to a method of treating a sigma-2 receptor mediated disorder or condition comprising administering a compound of formula (I) including Compound A, wherein the symptom is task completion issues and memory issues; wherein the compound is administered at a dose of between 8 mg and 32 mg; wherein the compound is administered between once daily and four times daily including twice daily. The method of the copending claims would anticipate the method of the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 24-46 are rejected.
No claim is allowed.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
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