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 . Claims 1-46 are currently pending.
Priority
This application claims priority as follows:
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Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 41 and 44 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to a “use” per se. The claimed recitation of a use, without reciting any steps, results in a claim which is not a proper process claim under 35 U.S.C. 101. See MPEP 2173.05(q).
Applicant should cancel claims 41 and 44.
Claim Rejections - 35 USC § 112
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 1-11, 13-15, 17-34, 36-40, 42-43 and 45-46 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.
Claims 1-11, 13-15 and 17-34 claim "an isomer” of the compound. The claims also claim a stereoisomer of the compound, which is appropriate. The general term “isomer” comprises structural isomers, which are isomers having the same empirical formula but different structures unrelated to the formula described in the claims. One of ordinary skill in the art would not be able to determine the scope of the isomer compounds included in these claims.
Claim 21 contains the word “allylyl” which is not a term of art. Maybe applicant means “allyl”.
Claim 37 recites “A method of inhibiting E1 in a subject in need thereof”.
It is unclear to whom the claimed compound is being administered. The claim does not point out who is a subject in need of E1 inhibition. -This rejection can be overcome by removing “in need thereof” from claim 37.
In claim 37, the term "a therapeutically effective amount" is unclear when the claim fails to state the function which is to be achieved (MPEP 2173.05(c)). -This rejection can be overcome by removing “therapeutically”.
Claim 40 recites the limitation "wherein the cancer is selected from…". There is insufficient antecedent basis for this limitation in the claim because it depends of claim 39 which does not mention “cancer”.- This rejection can be overcome by amending claim 40 to depend of claim 38.
Claims 36-40, 42-43 and 45-46 are rejected for containing the indefinite issues as above.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3, 9, 40, 42-43, 45 and 46 are rejected under 35 U.S.C. 112(d) or pre-AIA 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.
Claim 3 recites that R38 is imidazolidinyl, however, imidazolidinyl is a fully unsaturated nitrogen containing 5-membered heterocycle which is not encompassed by the definition of R38 of claim 1 and does not agree with the “partially unsaturated heterocyclyl” grouping in claim 3.
Claim 9 recites that R38 is imidazolidinyl or tetrahydroquinolinyl, however, imidazolidinyl is a fully unsaturated nitrogen containing 5-membered heterocycle which is not encompassed by the definition of R38 of claim 1, and tetrahydroquinolinyl is not a 10-membered heteroaryl and is not encompassed by the definition of R38 of claim 1
Claim 40 recites “the method of claim 39 wherein the cancer is selected from …”, however, claim 39 is drawn to a method for inhibiting cell proliferation and does not mention “cancer”.
Claims 42 and 46 claim a compound and recite “for use in treating an E1 related disease” and “wherein the disease is selected from…”. Claims 42 and 46 thus encompass the identical compounds of the claims of which these depend since the only difference is the recitation of an intended use.
Claims 43 and 45 claim “a medicament for treating an E1 related disease” of the compound of any one of claims 1-35 or composition of claim 36, and “wherein the disease is selected from…”. Claims 43 and 45 recite the intended use of the compound and composition and thus, claim the identical compounds of claims 1-35 and 36.
An intended use of a product will not limit the scope of the claim because it merely defines a context in which the invention operates. (Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003)). Additionally, a preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. (See MPEP 707.07(f) and 2141.02 I; In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and MPEP 2111.02 II; Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951)). In the instant case, the intended use does not create a structural difference and the body of the claim does not depend on the intended use for completeness but rather can stand alone. Consequently, the intended use is not limiting. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. Claims 42, 43, 45 and 46 do not further limit the subject matter of the claim upon which they depend. The examiner recommends canceling claims 42, 43, 45 and 46 to overcome this rejection.
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 1-5, 8, 11-12 and 36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 31, 34, 35, 37 and 54 of copending Application No. 17/435,855 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because subject matter of the instant claims, wherein R38 is 3-pyridinyl or 2-pyridinyl, is prima facie obvious and covered by the claims of the reference application.
The reference application teaches compounds of formula
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, within others, as a representation of what is claimed at claims 30, 31, 34, 35, 37. Such examples were prepared and tested. These are particular embodiments of the invention claimed in the reference application which also show the preferred definitions for the variables and substituents. Further, the compounds are particularly claimed at claim 54 of the reference application:
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.
The subject matter of instant claims 1-5, 8, 11-12 and 36 differs from the exemplified compounds only in the position of the pyridyl. The instant claims have a 3-pyridyl or a 2-pyridyl instead of a 4-pyridyl of the exemplified compounds of the reference application and claim. The instant claimed compounds wherein R38 is 3-pyridyl or 2-pyridyl are position isomers of said compounds of reference claim 54.
Finding of prima facie obviousness--rational and motivation
Someone preparing these compounds would be trained in organic chemistry, who would recognize the very close structural similarity and would expect the compounds to have similar properties. One of ordinary skill in the art would have been motivated to make the analogous pyridyl position isomers of said examples with the expectation of obtaining additional inhibitors of E1 enzyme. These obvious variants were covered by the claims of the reference application.
It is well established that position isomers are prima facie structurally obvious even in the absence of a teaching to modify. The isomer is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the position isomers. This circumstance has arisen many times. See In re Schechter and LaForge, 98 USPQ 144, 150, which states “a novel useful chemical compound which is homologous or isomeric with compounds of the prior art is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compounds.” Note also In re Deuel 34 USPQ2d 1210, 1214 which states, “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).” See also MPEP 2144.09, second paragraph, states, “Compounds which are position isomers or homologs are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties.” In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).
It has been held that compounds that differ only in the placement of substituents in a ring system are not patentable absent a showing of unexpected properties. See In re Jones, 74 USPQ 152 (CCPA 1947). Such structurally related compounds suggest one another and would be expected to share common properties absent a showing of unexpected results. In re Norris, 84 USPQ 458 (1950).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Objections
Claim 16 is objected to. Four compounds are repeated in the claim.
Claim 35 is objected to for depending of a rejected claim.
Conclusion
Claims 1-15, 17-34 and 36-46 are rejected. Claims 16 and 35 are objected to. No claim is in condition for allowance.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1759