DETAILED ACTION
Notice of Pre-AIA or AIA Status
The inventor or joint inventor should note that the instant invention, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 28-33 are pending in the instant invention. According to the Amendments to the Claims, filed August 30, 2024, claims 1-27 were cancelled and claims 28-33 were added.
Status of Priority
This invention is a Continuation (CON) of US Application No. 17/537,110, filed November 29, 2021 and now US 11,981,636, which is a Continuation (CON) of US Application No. 16/613,697, filed November 14, 2019 and now US 11,214,540, which is a 35 U.S.C. § 371 National Stage Filing of International Application No. PCT/US2018/032726, filed May 15, 2018, which claims priority under 35 U.S.C. § 119(e) to US Provisional Application No. 62/506,226, filed May 15, 2017.
Although the inventor’s or joint inventor’s claim for the benefit of a prior-filed invention under 35 U.S.C. § 119(e) is acknowledged, the inventor or joint inventor has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. § 119(e) as follows:
The later-filed invention must be an invention for a patent, for an invention which is also disclosed in the prior-filed invention (the provisional invention). The disclosure of the invention in the prior-filed invention and in the later-filed invention must be sufficient to comply with the requirements of 35 U.S.C. § 112(a). {See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)}.
The specification of the prior-filed invention, US Provisional Application No. 62/506,226, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. § 112(a) for one or more claims of this invention for the following reason: the specification in the instant invention has been amended with respect to the scope of Formula I, which now discloses amended definitions for at least Ra, Rb, Rc, Rd, and Re, respectively, and is no longer coextensive with that of US Provisional Application No. 62/506,226.
Consequently, since the specification of US Provisional Application No. 62/506,226 lacks adequate support or enablement for one or more claims of the instant invention, as defined below in Restrictions / Election of Species, and in the manner provided by 35 U.S.C. § 112(a), the first Office action on the merits of all relevant claims drawn to the instant invention will be prosecuted according to the earliest effective filing date afforded this invention, which is that of International Application No. PCT/US2018/032726, filed May 15, 2018.
Restrictions / Election of Species
PNG
media_image1.png
200
400
media_image1.png
Greyscale
The forthcoming first Office action and prosecution on the merits includes (1) claims 28 and 29, drawn to substituted pyrrolidines of the Formula I, shown to the right, and/or a pharmaceutical composition thereof; (2) claim 30, drawn to a method of treating Alzheimer’s disease, comprising administering… a pharmaceutical composition comprising a substituted pyrrolidine of the Formula I, shown to the right above; (3) claim 31, drawn to a method for inhibiting cognitive decline in a subject,,, comprising administering… a pharmaceutical composition comprising a substituted pyrrolidine of the Formula I, shown to the right above; (4) claim 32, drawn to a method of inhibiting amyloid beta effect on a neuronal cell, comprising administering… a pharmaceutical composition comprising a substituted pyrrolidine of the Formula I, shown to the right; and (5) claim 33, drawn to a method of treating mild cognitive impairment in Alzheimer’s disease in a subject in need thereof, comprising administering… a pharmaceutical composition comprising a substituted pyrrolidine of the Formula I, shown to the right above, respectively.
Thus, a first Office action and prosecution on the merits of claims 28-33 is contained within.
Specification Objection - Disclosure
The following guidelines illustrate the preferred layout for the specification of a utility application. These guidelines are suggested for the inventor’s or joint inventor’s use.
Arrangement of the Specification
As provided in 37 CFR 1.77(b), the specification of a utility invention should include the following sections in order. Each of the lettered items should appear in upper case, without underlining or bold type, as a section heading. If no text follows the section heading, the phrase Not Applicable should follow the section heading:
(a) TITLE OF THE INVENTION.
(b) CROSS-REFERENCE TO RELATED APPLICATIONS.
(c) STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR
DEVELOPMENT.
(d) THE NAMES OF THE PARTIES TO A JOINT RESEARCH AGREEMENT.
(e) INCORPORATION-BY-REFERENCE OF MATERIAL SUBMITTED ON A
COMPACT DISC.
(f) BACKGROUND OF THE INVENTION.
(1) Field of the Invention.
(2) Description of Related Art (including information disclosed under 37 CFR 1.97
and 1.98).
(g) BRIEF SUMMARY OF THE INVENTION.
(h) BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S).
(i) DETAILED DESCRIPTION OF THE INVENTION.
(j) CLAIM OR CLAIMS (commencing on a separate sheet).
(k) ABSTRACT OF THE DISCLOSURE (commencing on a separate sheet).
(l) SEQUENCE LISTING (See MPEP § 2424 and 37 CFR 1.821-1.825).
The inventor or joint inventor is advised to format the specification according to 37 CFR 1.77(b) above and 37 CFR 1.77(c). Revisions should particularly include and/or address: a) section headings (b-i), where applicable; and b) bold-type, underline, and/or upper case formatting. Appropriate correction may be required.
Specification Objection - Title
The inventor or joint inventor is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive and should contain fewer than 500 characters. See 37 CFR 1.72(a) and MPEP § 606.
The title of the invention is not technically accurate and descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. In the revised title, the examiner suggests additionally identifying the substituted pyrrolidines of the Formula I.
The following title is suggested: PHARMACEUTICAL COMPOSITIONS COMPRISING SUBSTITUTED PYRROLIDINES FOR TREATING NEURODEGENERATIVE DISEASES.
Appropriate correction is required.
Specification Objection - Abstract
The inventor or joint inventor is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, 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 reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b).
The examiner suggests incorporating the structure of Formula I into the abstract, to overcome this objection.
Claim Objections
Claim 28 is objected to because of the following informalities: for clarity, precision and to avoid issues under 35 U.S.C. § 112(b), the existing recitation should be replaced with the following recitation:
A compound of Formula I:
PNG
media_image2.png
200
400
media_image2.png
Greyscale
I
or a pharmaceutically acceptable salt or stereoisomer thereof,
wherein:
Ra is H, halo, C1-C10 alkyl, CF3, OH, OC1-C6 alkyl, S(O)2CH3, or morpholino;
Rb is H, halo, C1-C10 alkyl, CF3, OH, OC1-C6 alkyl, S(O)2CH3, or morpholino;
Rc is H, halo, C1-C10 alkyl, CF3, OH, OC1-C6 alkyl, S(O)2CH3, or morpholino;
Rd is H, halo, C1-C10 alkyl, CF3, OH, OC1-C6 alkyl, S(O)2CH3, or morpholino;
Re is H, halo, C1-C10 alkyl, CF3, OH, OC1-C6 alkyl, S(O)2CH3, or morpholino;
R1 is H, halo, C1-C10 alkyl, CH=C(CH3)2, or phenyl;
R2 is:
PNG
media_image3.png
200
400
media_image3.png
Greyscale
,
PNG
media_image4.png
200
400
media_image4.png
Greyscale
,
PNG
media_image5.png
200
400
media_image5.png
Greyscale
,
PNG
media_image6.png
200
400
media_image6.png
Greyscale
, or
PNG
media_image7.png
200
400
media_image7.png
Greyscale
; and
each R8 is independently H, C1-C10 alkyl, OH, S(O)2alkyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, C6-C10 aryl, or C5-C10 heteroaryl, wherein each C1-C10 alkyl, C3-C10 cycloalkyl, C3-C10 heterocycloalkyl, C6-C10 aryl, and C5-C10 heteroaryl is optionally and independently substituted with one or more substituents independently selected from the group consisting of halo, alkyl, perfluoroalkyl, alkyl-OH, alkyl-O(alkyl),C(O)alkyl, C(O)Oalkyl, C(O)cycloalkyl, C(O)aryl, OH, O(alkyl), O(alkyl)-O(alkyl), OC(O)NHCH(CH3)2, O(aryl), S(O)2CH3, S(O)2N(CH3)2, C3-C10 cycloalkyl, methylpiperidinyl, heterocyclyl, phenyl-S(O)2CH3, C5-C10 aryl, pyridinyl-N(CH3)2, pyridinyl-pyrrolidinyl, pyridinyl-morpholinyl, and C3-C10 heteroaryl.
Appropriate correction is required. See MPEP § 2173.02.
Claim 29 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A pharmaceutical composition comprising a pharmaceutically acceptable carrier or diluent and a therapeutically effective amount of a compound of claim 28, or a pharmaceutically acceptable salt or stereoisomer thereof.
Appropriate correction is required. See MPEP § 2173.02.
Claim 30 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating Alzheimer’s disease in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 29.
Appropriate correction is required. See MPEP § 2173.02.
Claim 31 is objected to because of the following informalities: for brevity, clarity and precision, the existing recitation should be replaced with the following recitation:
A method for inhibiting cognitive decline in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 29.
Appropriate correction is required. See MPEP § 2173.02.
Claim 32 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for inhibiting the amyloid beta effect on a neuronal cell in a subject, wherein the method comprises contacting at least one neuronal cell of the subject with a therapeutically effective amount of the pharmaceutical composition of claim 29.
Appropriate correction is required. See MPEP § 2173.02.
Claim 33 is objected to because of the following informalities: for clarity and precision, the existing recitation should be replaced with the following recitation:
A method for treating mild cognitive impairment in Alzheimer’s disease in a subject, wherein the method comprises administering to the subject in need thereof a therapeutically effective amount of the pharmaceutical composition of claim 29.
Appropriate correction is required. See MPEP § 2173.02.
Claim Rejections - 35 U.S.C. § 112(b)
The following is a quotation of the second paragraph of 35 U.S.C. § 112:
(b) CONCLUSION. The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or joint inventor regards as the invention.
Claims 28-33 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to set forth the subject matter which the inventor or joint inventor regards as the invention.
The inventor or joint inventor should note that claim 28 recites the limitation, sulfonyl, with respect to R8, where the limitation is implausible, resulting in an incomplete valence. Claims are unduly speculative where they define only a portion of a substituted pyrrolidine of the Formula I. Consequently, since incomplete valences are not permitted in the structure of the substituted pyrrolidines of the Formula I, an essential portion of the substituted pyrrolidines of the Formula I is indefinite and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the substituted pyrrolidines of the Formula I. {See Ex parte Pedlow and Miner, 90 USPQ 395 (Bd. Pat. App. & Int. 1951)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Similarly, the inventor or joint inventor should further note that the phrase, optionally substituted, in claim 28, with respect to R8, is a relative phrase which renders the claim indefinite. The phrase, optionally substituted, is not defined by the claim, the specification does not provide an adequate standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the metes and bounds of the invention. The specification, on page 16, uses open language, such as include, but are not limited to, to define the phrase, substituent groups, using a boiler plate list of functional groups, such as alkanoyl, alkoxy, etc., and further discloses that the substituents themselves may be further substituted; however, neither the specification, nor the claim, explicitly limits the invention to any specifically disclosed or recited embodiments. Consequently, the substituted pyrrolidines of the Formula I have been rendered indefinite by the use of the phrase, optionally substituted, with respect to R8.
Moreover, the inventor or joint inventor should further note that [C]laims which depend from indefinite claims are also indefinite. {See Ex parte Cordova, 10 USPQ 2d 1949, 1952 (PTO Bd. App. 1989)}.
The examiner suggests amending the claims, particularly as stated in the section above entitled Claim Objections, to overcome this section of the rejection.
Claim Rejections - Obviousness-type 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 obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined invention claim is not patentably distinct from the reference claims because the examined invention claim is either anticipated by, or would have been obvious over, the reference claims. {See 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); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969)}.
Consequently, claims 28-33 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over at least claims 1, 3 and 5-8 of US Patent No. 11,214,540. Although the conflicting claims are not identical, they are not patentably distinct from each other because claim 1 in US 11,214,540 recites substituted pyrrolidines of the Formula I, where Ra = -H; Rb = -H; Rc = -CF3; Rd = -H; Re = -H; R1 = -CH=C(CH3)2; and R2 = -optionally substituted cyclic amnio group ((S)-3-hydroxypyrrolidin-1-yl), respectively, which provide overlapping subject matter with respect to the instantly recited substituted pyrrolidines of the Formula I, where Ra = -H; Rb = -H; Rc = -CF3; Rd = -H; Re = -H; R1 = -CH=C(CH3)2; and R2 = -3-hydroxypyrrolidin-1-yl, respectively.
The inventor or joint inventor should note that [A] pure optical isomer is not patentable over the racemic mixture unless it possesses properties not possessed by the racemic mixture. {See In re Anthony, 414 F.2d 1383, 162 USPQ 594, (CCPA 1969)}.
Similarly, the inventor or joint inventor should further note that [T]he discovery of a previously unappreciated property of a prior art compound, or of a scientific explanation for the prior art’s functioning, does not render the old compound patentably new to the discoverer. {See Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999)}.
Likewise, the inventor or joint inventor should further note that [T]he 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. {See In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977); and In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004)}.
Next, the inventor or joint inventor should note that [W]hen the claim recites using an old compound and the use is directed to a result or property of that compound, then the claim is anticipated. {See In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978); and In re Tomlinson, 363 F.2d 928, 150 USPQ 623 (CCPA 1966)}.
Then, the inventor or joint inventor should further note that [P]roducts of identical chemical composition may not have mutually exclusive properties. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties the inventor or joint inventor discloses and/or claims are necessarily present. {See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990)}.
Moreover, the inventor or joint inventor should further note that a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 37 CFR 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground, provided the conflicting invention or patent either is shown to be commonly owned with this invention, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Furthermore, the inventor or joint inventor should also note that the USPTO internet Web site contains terminal disclaimer forms which may be used, and the inventor or joint inventor is encouraged to visit http://www.uspto.gov/forms/, where (i) the filing date of the invention will determine what form should be used, and (ii) a web-based eTerminal Disclaimer may be filled out completely online using web-screens, respectively.
Also, the inventor or joint inventor should further note that an eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission.
Finally, for more information about eTerminal Disclaimers, the inventor or joint inventor should refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Allowable Subject Matter
No claims are allowed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS M. WILLIS, whose telephone number is 571-270-5757. The examiner may normally be reached on Monday thru Thursday from 8:00-6:00 EST. The examiner is also available on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mr. Jeffrey Murray, may be reached on 571-272-9023. The fax phone number for the organization where this invention or proceeding is assigned is 571-273-8300.
Information regarding the status of an invention may be obtained from Patent Center. For more information about Patent Center, see https://www.uspto.gov/patents/apply/patent-center. Should you have questions on access to Patent Center, contact the Patent Electronic Business Center (PEBC) at 866-217-9197 (toll-free) or ebc@uspto.gov.
/DOUGLAS M WILLIS/
Primary Examiner, Art Unit 1624
Prosecution Insights