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 1-19 are pending in the instant application.
Domestic Benefit
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/209,841, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The prior-filed Application No. 63/209,841 fails to disclose the full scope of compounds recited at instant Claim 1. Application No. 63/209,841 discloses only a pharmaceutical composition comprising NNI-362 (
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) as the API.
Therefore, Claims 1-19 of the instant application do not receive the benefit of the filing date of Application No. 63/209,841.
Acknowledgement is made of Applicant’s claim for domestic benefit based on the 63/340,230 application, filed May 10th, 2022. Claims 1-19 are fully supported by this application, and will be evaluated with an effective filing date of May 10th, 2022.
Information Disclosure Statement
The Information Disclosure Statements filed on October 16th, 2024 and November 19th, 2025 have been fully considered by the examiner, except where marked with a strikethrough.
Specification
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.
The abstract of the disclosure is objected to because it is fewer than 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which Applicant may become aware of in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities:
For the recited definitions of R8, “-C(O)R9” and “-C(O)N(R9)2” are erroneously listed twice.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-19 are 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 a composition comprising a compound of formula (I) in which R1 is H, F, Cl, Br, or R7 is a substituted methyl, R3 is (CH2)m, wherein m is 2 or 3, R4 is N and R8 is X, R9 wherein R9 is H or alkyl, or -OR9 wherein R9 is alkyl, does not reasonably provide enablement for compositions comprising a compound of formula (I) for which these variables are otherwise defined. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
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.
Nature of the invention:
The invention is drawn to a pharmaceutical composition comprising a compound of formula (I) as recited at instant Claim 1.
Breadth of the invention:
The scope of the claimed invention is very broad, as it is drawn to a pharmaceutical composition comprising a compound of the formula:
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allowing for any of the myriad combinations of the variables as recited.
State of the prior art 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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
The compound core depicted with specific substituents represents a narrow subgenus for which applicant has provided sufficient guidance to make and use; however, the disclosure is not sufficient to allow extrapolation of the limited examples to enable the scope of the compounds instantly claimed. Applicant has provided no working example of any compound in which R1, R7, R3, R4, R8, and R9 were defined as anything other than the options as noted above in the instant application.
Within the specification, “specific operative embodiments or examples of the invention must be set forth. Examples and description should be of sufficient scope as to justify the scope of the claims.” Markush claims must be provided with support in the disclosure for each member of the Markush group. Where the constitution and formula of a chemical compound is stated only as a probability or speculation, the disclosure is not sufficient to support claims identifying the compound by such composition or formula. See MPEP 608.01(p).
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 that Applicant is not enabled for making these compounds.
Claims 16-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
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.
Nature of the invention:
The invention is drawn to a method of treating a condition selected from developmental delay, psychiatric disorders, neurodegenerative disease, neurological disorders, and aging.
Breadth of the invention:
The scope of the claimed invention is very broad. In addition to the breadth of compounds claimed for administration, the range of diseases and/or disorders is very broad. Further, the scope includes, for example, disorders not yet known, but are discovered years from now and later classified as psychiatric disorders or neurological disorders. Can an Applicant simply “reach through” and gain patent protection for the treatment of disorders that are not yet known, or disorders presently known that are later reclassified to fall within one of the broad categories listed?
State of the prior art and predictability in the art:
With respect to the active pharmaceutical ingredients instantly disclosed, Kelleher-Anderson (US 8,999,872 B2; cited on Applicant’s Information Disclosure Statement filed October 16th, 2024); hereinafter referred to as Kelleher-Anderson) represents the state of the prior art.
Kelleher-Anderson discloses examples of compounds that read on the instantly claimed Formula (I) as recited at instant Claim 1. For example, at Claim 1 of Kelleher-Anderson,
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is disclosed, which reads on the instantly recited Formula (I). Kelleher-Anderson teaches these compounds as administered in a method for stimulating neurogenesis and inhibiting neuronal degeneration in a mammal. No evidence is provided therein, however, enabling the administration of compounds of formula (I) for the broad treatment of the diseases and/or disorders instantly recited.
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).
In terms of the law, MPEP 2107.03 states “evidence of pharmacological or other biological activity of a compound will be relevant to an asserted therapeutic use if there is reasonable correlation between the activity in question and the asserted utility. Cross v. Iizuka, 753 F. 2d 1040, 224 USPQ 739 (Fed. Cir. 1985); In re Jolles, 628 F. 2d 1322, 206 USPQ 885 (CCPA 1980); Nelson v. Bowler, 626 F. 2d 853, 206 USPQ 881 (CCPA 1980).” If correlation is lacking, it cannot be relied upon, Ex parte Powers, 220 USPQ 924; Rey-Bellet and Spiegelberg v. Engelhardt v. Schindler, 181 USPQ 453; Knapp v. Anderson, 177 USPQ 688. Indeed, the correlation must have been established “at the time the tests were performed”, Hoffman v. Klaus, 9 USPQ2d 1657.
Level of ordinary skill in the art:
An ordinary artisan in the area of drug development would have experience in synthesizing chemical compounds for particular activities. The synthesis of new drug candidates, while complex, is routine in the art. The process of finding new drugs that have in vitro activity against a particular biological target (i.e., receptor, enzyme, etc.) is well known. Additionally, while high throughput screening assays can be employed, developing a therapeutic method, as claimed, prior to synthesizing and testing compounds is generally not well-known or routine, given the complexity of certain biological systems.
The amount of direction provided and working examples:
Beginning at Page 34, Applicant sufficiently discloses examples to demonstrate efficacy of absorption by a human, disclosing plasma concentrations for a variety of cohorts dosed with differing concentrations and frequency of doses of the API. No examples, however, have been disclosed to demonstrate the treatment of any of the broadly claimed diseases or disorders.
Quantity of experimentation needed to use the invention based on the content of the disclosure:
The quantity of experimentation needed is undue experimentation. As alluded to above, a person having ordinary skill in the art would need to identify and/or develop metrics by which to evaluate the efficacy of the instantly claimed APIs in treating the diseases and/or disorders instantly claimed, with no assurance of success.
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.
The specification fails to provide enough support for the broadly claimed method of treating developmental delay, psychiatric disorders, neurodegenerative disease, neurological disorders, and aging.
Genentech Inc. v Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “patent protection is granted in return for enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
Therefore, in view of the Wands factors and In re Fisher (CCPA 1970) discussed above, to practice the claimed invention herein a person having ordinary skill in the art would have to engage in undue experimentation to determine the efficacy of administration of a composition comprising the instantly claimed APIs, with no assurance of success.
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 1-3 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 recites the limitation that R4 can be (CHn), wherein n is 2. This renders the claim indefinite, as defining n as 2 would require more than four bonds to carbon.
Claim 2 recites the following structures:
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,
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. There is insufficient antecedent basis for this limitation in the claim. In the first three structures, reproduced above, R1 is defined as -O-R7, wherein R7 is unsubstituted 1 or 2 carbon alkyl. Claim 1, from which Claim 2 depends, requires R7 to be substituted 1-6 carbon alkyl. The fourth structure, reproduced above, is not a compound of formula (I).
Claim 3 recites the structure
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. As in Claim 2, there is insufficient antecedent basis for this limitation in the claim as R1 is defined as -O-R7-, wherein R7 is unsubstituted 2 carbon alkyl. Claim 1, from which Claim 3 depends, requires R7 to be substituted 1 to 6 carbon alkyl.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 15-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kelleher-Anderson (US 8,039,462 B2; hereinafter referred to as Kelleher-Anderson).
Regarding Claim 1, at Column 29, Kelleher-Anderson teaches the following compound of Formula XII:
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This compound reads on a compound of Formula (I) as recited at instant Claim 1 when the variables are defined as follows:
Two R1 variables are H, and the third R1 is F.
R2 is S.
R3 is (CH2)m, wherein m is 2.
R4 is N.
R6 is H.
Four R8 variables are R9, wherein R9 is H, and the fifth R8- is -OR9, wherein R9 is alkyl.
Additionally, this compound is the first compound recited at Claim 2.
With respect to the limitations regarding a pharmaceutical composition comprising a compound of formula (I) in a lipid formulation, at Column 29, Lines 54-56 teach administration of a pharmaceutical composition comprising a compound of Formula XII, above. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Anderson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
Further, at Column 30, Kelleher-Anderson teaches a compound of Formula XIII:
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This compound reads on a compound of formula (I) as recited at instant Claim 1 when the variables are defined as follows:
One R1 is H, and the other two R1 variables are F.
R2 is O.
R3 is (CH2)m, wherein m is 2.
R4 is N.
R6 is H.
Four of the R8 variables are R9, wherein R9 is H, and the fifth R8 variable is -OR9, wherein R9 is alkyl.
This compound is recited at Claim 2 at the first entry of the third row of compounds at Page 4.
With respect to the limitations regarding a pharmaceutical composition comprising a compound of formula (I) in a lipid formulation, at Column 29, Lines 65-67 teach administration of a pharmaceutical composition comprising a compound of Formula XIII, above. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Anderson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
Further, at Column 30, Kelleher-Anderson teaches a compound of Formula XIV:
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This compound reads on a compound of formula (I) as recited at Claim 1 when the variables are defined as follows:
Two of the R1 variables are H, and the third is F.
R2 is O.
R3 is (CH2)m, wherein m is 3.
R4 is N.
R6 is H.
Four of the R8 variables are R9, wherein R9 is H, and the fifth is -OR9, wherein R9 is alkyl.
This compound is recited at Claim 2, at the third row, second entry of Page 4.
With respect to the limitations regarding a pharmaceutical composition comprising a compound of formula (I) in a lipid formulation, at Column 30, Lines 25-28 teach administration of a pharmaceutical composition comprising a compound of Formula XIV, above. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Anderson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
At Column 36, Kelleher-Anderson teaches the following compound:
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This compound reads on a compound of formula (I) as recited at instant Claim 1 when the variables are recited as follows:
Two of the R1 variables are H, and the third R1 is F.
R2 is S.
R3 is (CH2)m-, wherein M is 3.
R4 is N.
R6 is H.
Four of the R8 variables are R9, wherein R9 is H, and the fifth R8 variables is -OR9, wherein R9 is alkyl.
Additionally, this compound is recited at instant Claim 4.
Regarding Claim 3, at Table 1, Kelleher-Anderson teaches the following compound:
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Kelleher-Anderson teaches at Column 12, Lines 37-39 that compounds of Table 1 comprise embodiments of the invention including compositions comprising these compounds. At Column 17, Line 63 through Column 18, Line 4, Kelleher-Anderson teaches the pharmaceutical compositions are suitable for inclusion of excipients including lipids in an amount ranging from 1-99.99% by weight or volume.
Regarding Claim 15, Kelleher-Anderson teaches at Column 20, Line 36, oral administration via capsule. Regarding Claim 16, Kelleher-Anderson teaches at Column 37, Lines 24-29 that the aforementioned compositions can be administered to treat a condition including neurodegenerative disease, psychiatric disorders, and/or aging. Regarding Claim 17, Kelleher-Anderson teaches at several places administration of these compositions to a mammal, for example, At Column 29, Lines 49-55. Regarding Claim 18, at Column 17, Lines 39-42, Kelleher-Anderson teaches the beneficial effects can be observed after administration to animals including pets and farm animals. Regarding Claim 18, at Lines 39-42, Kelleher-Anderson additionally teaches administration of these compositions to humans.
Claim Rejections - 35 USC § 103
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.
Claims 5, 6, 8, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Kelleher-Anderson (US 8,039,462 B2; hereinafter referred to as Kelleher-Anderson).
As noted above, Claim 1, from which Claim 5 depends, is anticipated by Kelleher-Anderson.
Regarding Claim 5, Kelleher-Anderson does not teach a single embodiment of a composition with each of the components in the ranges disclosed.
Kelleher-Anderson does, however, teach at Column 21, Lines 60-63, that the compound that is the API is present in an amount ranging from 0.005% to 30% by weight. Kelleher-Anderson teaches the use of vegetable oil as a vehicle at Column 21, Line 57. At Column 19, Lines 30-44, Kelleher-Anderson teaches the inclusion of surfactants. At Column 21, Lines 34-40, Kelleher-Anderson teaches the inclusion of thickening agents. Though Kelleher-Anderson is silent with respect to the specific amounts of vehicle, surfactant, and thickening agent to use, per MPEP 2144.05, II., A., “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.”
Regarding Claim 6, at Column 21, Lines 55-62, Kelleher-Anderson teaches vegetable oils as a suitable liquid carrier in the pharmaceutical compositions.
Regarding Claim 8, at Column 19, Line 35, Kelleher-Anderson teaches the inclusion of polyethylene glycol. At Column 20, Line 1, Kelleher-Anderson teaches the inclusion of lecithin. At Column 19, Line 57, Kelleher-Anderson teaches inclusion of cholesterol.
Regarding Claim 11, at Column 20, Line 46, Kelleher-Anderson teaches the inclusion of waxes.
Taken together, this would result in the practice of Claims 5, 6, 8, and 11 with 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 1-2 and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5-10 of U.S. Patent No. 8,039,462. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and US Patent No. ‘462 are drawn to overlapping pharmaceutical compositions.
To demonstrate the overlap, instant Claims 1 and 2 are drawn to a pharmaceutical composition comprising the following compound:
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This compound reads on the formula recited at Claims 5, 7, and 9 of US Patent No. ‘462.
Additionally, instant Claims 1 and 4 are drawn to a pharmaceutical composition comprising the following compound:
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This compound reads on the formula recited at Claims 5, 7, and 9 of US Patent No. ‘462.
The claims differ in that instant Claim 1 recites the additional limitation that the pharmaceutical composition is a lipid formulation. While Claims 5-10 of US Patent No. ‘462 are silent with respect to the inclusion of lipids, the compositions instantly claimed read on the limitations recited at Claims 5-10 of US Patent No. ‘462.
Claim 15 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 8,999,972. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application and US Patent No. ‘972 are both drawn to delivering overlapping pharmaceutical compositions to a mammal.
Claim 1 of US Patent No. ‘972 is drawn to a method of stimulating neurogenesis and inhibiting neuronal degeneration in a mammal comprising administering a pharmaceutical composition comprising a compound that includes, for example, the following compound:
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This compound reads on a compound of formula (I) as recited at instant Claim 1, from which instant Claim 15 depends, when the variables are defined as follows:
Two R1 variables are H, and the third is F.
R2 is O.
R3 is (CH2)m, wherein m is 3.
R4 is N.
R6 is H.
Four R8 variables are H, and the fifth is -OR9, wherein R9 is alkyl.
Instant Claim 15 differs from Claim 1 of US Patent No. ‘972 in that the instant Claim is drawn to a method of delivering an API to a mammal. Practicing Claim 1 of US Patent No. ‘972 reads on this claim, as the method of stimulating neurogenesis and inhibiting neuronal degeneration in a mammal comprising administering a compound, as above, necessarily requires the API to be delivered to the mammal, as instantly claimed.
Conclusion
Claims 1-19 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL JOHN BURKETT whose telephone number is (703)756-5390. The examiner can normally be reached Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.J.B./ Examiner, Art Unit 1624
/JEFFREY H MURRAY/ Supervisory Patent Examiner, Art Unit 1624