DETAILED 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 .
This is a Final Office Action.
Claims 1 and 8-11 are pending and under consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: when part a) is five, the scope is the same as parts b). Appropriate correction is required.
Claim 1 is objected to because of the following informalities: parts d) and e) are the same. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: the term “and” is needed prior to the term “optionally” in line 4. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The rejection of claims 2-7 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends, is withdrawn based on the amendments.
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 9 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of schizophrenia, bipolar disorder, depression, and sleep and behavioral disturbances in dementia, does not reasonably provide enablement for a method of treating autism or other neuropsychiatric disorders, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed most recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (1) The breadth of the claims; (2) The nature of the invention; (3) The state of the prior art; (4) The level of one of ordinary skill; (5) The level of predictability in the art; (6) The amount of direction provided by the inventor; (7) The existence of working examples; and (8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(A) Breadth of claims.
(a) Scope of the compounds. The compounds are drawn to a crystalline form F1 of lumateperone ditosylate.
(b) Scope of the diseases covered. The scope is drawn to a method of treating autism or other neuropsychiatric disorders, generally.
Neurological Disorders are extremely diverse, and fall into an assortment of categories.
The scope was provided in the previous office action and is incorporated here.
(B) The nature of the invention and predictability in the art: The invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(C) Direction or Guidance: That provided is very limited. The dosage range information is not found in the specification for the many disorders covered by the specification. Thus, there is no specific direction or guidance regarding a regimen or dosage effective specifically for CNS disorders generally.
(D) State of the Prior Art: These compounds are a specific crystalline form F1 of lumateperone ditosylate. So far as the examiner is aware, lumateperone ditosylate of any kind has not been used for the treatment of the plethora of diseases, disorders or conditions embraced by the scope.
(E) Working Examples: There are no in vitro assays drawn to the treatment of the many diseases, disorders or conditions embraced by the scope.
(F) Skill of those in the art: The skill level is quite low in the art of neurodegenerative disorders.
The skill level in the art art was provided in the previous office action and is incorporated here.
In summary, vast numbers of CNS disorders have no pharmacological treatment at all, and of those that do, none or virtually none have been treated with such inhibitors as are disclosed here. Some of the most devastating neurological diseases, such as many brain tumors, mental retardation and autism and ALS and dyslexia have no pharmaceutical treatments at all.
(G) The quantity of experimentation needed: Especially in view of points A, D and F, this is expected to be great.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Applicant traverses by stating, “Before the effective filing date of claim 9, it was known in the art that Lumateperone can be used in methods of treating autism or other neuropsychiatric disorders. For example, see W02015085004A1 at paragraphs [0006], [0015], and [0116]. Compound A, Example 1 of this reference refers to the compound of Formula I wherein X is -N(CH3)- and Y is -C(O)-, tosylate salt, which is Lumateperone tosylate salt. (WO2015085004A1, page 43, [0108].)”
This is not persuasive. The reference was not provided for consideration. Moreover, citing a publication that merely states a utility without evidence is not sufficient to overcome an enablement rejection.
Applicant further states, “The Compounds of Formula I combine potent serotonin 5- HT2A receptor antagonism, dopamine receptor phosphoprotein modulation, or DPPM, glutamatergic modulation and serotonin reuptake inhibition into a single drug candidate for the treatment of acute and residual schizophrenia. At dopamine D2 receptors, the Compounds of Formula I have dual properties and act as both post-synaptic antagonists and pre-synaptic partial agonists. The Compounds of
Formula I also stimulate phosphorylation of glutamatergic NMDA NR2B, or GluN2B, receptors in a mesolimbic specific manner.”
This is also unpersuasive. As noted in the rejection above, the application is enabled for the treatment of schizophrenia, bipolar disorder, depression, and sleep and behavioral disturbances in dementia. Also noted in the rejection, neuropychiatric disoders are diverse and many are not known to be treated through the presently disclosed mode of action. Thus, the rejection is maintained.
Double Patenting
The rejection of claims 1-11 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 11332469, is withdrawn based on the terminal disclaimer received by the Office.
The rejection of claims 1-11 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11760757, is withdrawn based on the terminal disclaimer received by the Office.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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