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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on July 18, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-9, 11-12 and 15-18) in the reply filed on July 18, 2025, is acknowledged.
Applicant further election of schizophrenia as the species corresponding to the neurodevelopmental disorder is also acknowledged.
Status of Claims
Claims 1-9, 11-12, 15-20, 22-23 and 26-35 are currently pending and are the subject of this office action.
Claims 19-20, 22-23 and 26-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on March 5, 2015.
Claims 4-9 are further withdrawn since they do not encompass the elected species (schizophrenia)
Claims 1-3, 11-12 and 15-18 are presently under examination as they relate to a method of treating schizophrenia.
Due to Applicant’s election of “schizophrenia” as the species corresponding to the neurodevelopmental disease being treated, the examination of the instant claims is restricted to “treatment of schizophrenia”. All other diseases within the claims are not being examined, since they are not considered part of the elected invention, as such it is suggested that Applicant amends the claims accordingly to remove all non-elected inventions (see Improper Markush Group rejection below).
Priority
The present application is a 371 of PCT/JP2019/051605 filed on 12/27/2019 and claims priority to foreign application JAPAN JP2018-245688 filed on 12/27/2018.
Claim Rejections- Improper Markush Group.
Claims 1-3, 11-12 and 15-18 are rejected under Improper Markush Group.
The improper Markush Group Rejection is based on a judicially approved doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an "improper Markush grouping" if: (1) the species of the Markush group do not share a single structural similarity," or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
Claims 1-3, 11-12 and 15-18 are rejected on the grounds of containing “improper Markush grouping”, which contain species that fail to share a common use.
Claims 1-3, 11-12 and 15-18 encompass a wide variety of diseases (i.e. treating: schizophrenia, autism, a learning disorder, attention deficit disorder, etc.) which are known to have different etiologies and pathophysiologies, have different stages of progression and require different treatments and patient populations.
To overcome this rejection, Applicant should amend the above claims (1-3, 11-12 and 15-18), so they only recite schizophrenia as the only disease being treated.
Claim Rejections - 35 USC § 102
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 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.
Claim(s) 1-3, 11-12 and 15-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hashimoto (WO 2015/037248 March 19, 2015).
NOTE: While the examination has not been expanded beyond the elected disease: schizophrenia, the following rejection is made to further prosecution with regards to the claims that are being anticipated by the prior art regarding the broader genus of neurodevelopmental diseases, more specifically: autism.
For claims 1-3 and 11-12, Hashimoto teaches a method of treating depressive symptoms comprising administering to a subject suffering from autism a composition comprising R-ketamine, substantially free of the S-ketamine enantiomer (See [0001] and [0013]).
The prior art does not teach treatment of a neurodevelopmental disorder, wherein the developmental disorder is autism.
However: “treating autism” will inevitably flow from the teachings of Hashimoto, since the same compound (R-ketamine substantially free of S-ketamine) is being administered to the same subjects (subjects that suffer from autism). In other words, products of identical composition cannot exert mutually exclusive properties when administered under the same circumstances.
In other words, even though the prior art is silent regarding “treating autism”, by practicing the method of Hashimoto: “the administration of a composition comprising R-ketamine substantially free of S-ketamine to a subject suffering from autism", one will also be “treating autism”, even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage ("treating autism”) of the method disclosed by Hashimoto (“the administration of a composition comprising R-ketamine substantially free of S-ketamine to a subject suffering from autism").
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).”
For claim 15, Hashimoto teaches that R-ketamine can be formulated as a pharmaceutical composition (see [0001]).
For claim 16, Hashimoto teaches that the pharmaceutical composition is suited for oral administration (see [0043]).
For claim 17, Hashimoto teaches that the pharmaceutical composition is in the form of a tablet, capsule, etc. (See [0043]).
For claim 18, Hashimoto teaches that the effective amounts are:
From about 0.01 to 1000 mg/person/day for parenteral administration, and
From 0.01 to 500 mg/person/day for oral administration (See [0051]).
Hashimoto does not teach that the above amounts are effective to treat autism. However, the specification fails to disclose any “effective” amount for treating any neurodevelopmental disorder, including autism.
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the “effective amount” used in the method of the prior art does not possess the same material, structural and functional characteristics of the “effective amount” claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the “effective amount” used in the claimed method is different from the “effective amount” taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
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.
1) Claims 1-3, 11-12 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 10,406,121. Although the claims at issue are not identical, they are not patentably distinct from each other because: the ‘121 patent teaches a method of treating dementia, wherein the dementia is Alzheimer’s disease (a neurodevelopmental disorder) comprising the administration of a composition comprising R-ketamine, substantially free of S-ketamine.
2) Claims 1-3, 11-12 and 15-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,207,279. Although the claims at issue are not identical, they are not patentably distinct from each other because: the ‘279 patent teaches a method of treating dementia, wherein the dementia is Alzheimer’s disease (a neurodevelopmental disorder) comprising the administration of a composition comprising R-ketamine, substantially free of S-ketamine
3) Claims 1-3, 11-12 and 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-46 and 55-57 of copending Application No. 18/545,395 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because: the copending application teaches a method of treating dementia, wherein the dementia is Alzheimer’s disease (a neurodevelopmental disorder) comprising the administration of a composition comprising R-ketamine, substantially free of S-ketamine
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
4) Claims 1-3, 11-12 and 15-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-14 of copending Application No. 18/508,831 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because: the copending application teaches a method of treating Alzheimer’s disease (a neurodevelopmental disorder) comprising the administration of a composition comprising R-ketamine, substantially free of S-ketamine
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 21, 2025.