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 .
Priority
This application is a 371 of PCT/US2022/037756 (07/20/2022)
PCT/US2022/037756 has PRO 63/223,788 (07/20/2021).
Election/Restrictions
Applicant's election without traverse of Group I, drawn to a compound for formula (I), in the reply filed on 7/30/26 is acknowledged.
Applicant also elected the following species:
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113
553
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corresponding to formula (I) when
Q is
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93
112
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where R1-R2 form a substituted C6-aryl;
A is
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93
121
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where D is C6-aryl, R5 is Cl, Y is CR7, R6-R7 form a substituted 6-membered heterocyle;
L1 is C4-alkylene substituted by C1-alkyl-C6-aryl; L2 is NH; L3 is C(O); L4 is a bond;
stated to read on claims 1, 11, 19, 23, 30, 38, 59, 76, and 89-91.
As detailed in the following rejections, the generic claim encompassing the elected species was not found patentable. Therefore, the provisional election of species is given effect, the examination is restricted to the elected species only, and claims not reading on the elected species are held withdrawn. MPEP 803.02; Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (Bd. Pat. App. lnt. 1987). Accordingly, claims 65, 71, 92 are hereby withdrawn.
Should applicant, in response to this rejection of the Markush-type claim, overcome the rejection through amendment, the amended Markush-type claim will be reexamined to the extent necessary to determine patentability of the Markush-type claim. See MPEP 803.02.
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.
Claims 1, 11, 19, 23, 30, 38, 59, 76, and 89-91 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention.
The claim uses the language “Hal”, such as in the following, which is not defined in the specification and does not have an accepted meaning in the art such that it renders the claim indefinite:
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142
842
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Claim 1 has several illegible structures, such as the following, that renders the claim indefinite:
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117
600
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110
508
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.
Thus, the claims and those that depend therefrom are indefinite.
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, 89-91 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burhlane et al. (WO2020086595).
Burhlane teaches the following compound (claim 39):
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176
769
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and one of skill in the art would at once envisage the stereoisomers (p. 53-54: “When a disclosed compound is named or depicted by structure without indicating the stereochemistry, and the compound has at least one chiral center, it is to be understood that the name or structure encompasses either enantiomer of the compound free from the corresponding optical isomer, a racemic mixture of the compound or mixtures enriched in one enantiomer relative to its corresponding optical isomer.”) and as in the instant claims.
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 1, 11, 19, 23, 30, 38, 59, 76 are rejected under 35 U.S.C. 103 as being unpatentable over Burhlane et al. (WO2020086595) in view of Schauer et al. (Sci Rep 10, 5324, 24 March 2020, 15 pages) and Wermuth (“The Practice of Medicinal Chemistry”, 4th ed. (2015), Ch. 8, pages 181-241).
Burhlane teaches USP7 inhibitors including the following compounds:
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146
740
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146
753
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with experimentally determined activity in Table 1 5 (++++) and 40 (++). Burhlane teaches a genus with scope of alternatives where the Cl in compound 5 above is also F (Claim 1 teaches R2 includes H, Cl, Br, F).
Although Burhlane teaches a genus which encompasses species within the instant claims, Burhlane does not specifically teach an embodiment where the halogen Cl is replaced with F.
Schauer teaches USP7 inhibitors and a structure-activity-relationship study where the R2 group is varied among alternatives including Cl and H which affected the activity of the compound as shown in Fig. 3:
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481
610
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Wermuth teaches the well-known technique in the art known as bioisosterism which is routinely used by those of ordinary skill in the art in the development of pharmaceuticals. Wermuth specifically teaches halogens as classical bioisosteres include Cl and F and can be interchanged with an expectation of similar biological activity (p. 181-187; Table 8.4).
One of ordinary skill in the art would have considered interchanging the Cl substitution with F in order to optimize the activity of the inhibitor in the same manner done by Schauer and would have had a reasonable expectation of success due to Burhlane teaching a scope including the same modification as well as Wermuth’s teaching the bioisosteric relationship. With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a 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, 11, 19, 23, 30, 38, 59, 76, and 89-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-19 of U.S. Patent No. 12692250 in view of over Burhlane et al. (WO2020086595), Schauer et al. (Sci Rep 10, 5324, 24 March 2020, 15 pages) and Wermuth (“The Practice of Medicinal Chemistry”, 4th ed. (2015), Ch. 8, pages 181-241). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a genus of compounds which when one of ordinary skill in the art construed the scope of the claims would consider species disclosed in the specification including ones as in the 103 rejection supra and renders the instant claims obvious for the reasons provided above.
Claims 1, 11, 19, 23, 30, 38, 59, 76, and 89-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-18 of U.S. Patent No. 12503453 in view of over Burhlane et al. (WO2020086595), Schauer et al. (Sci Rep 10, 5324, 24 March 2020, 15 pages) and Wermuth (“The Practice of Medicinal Chemistry”, 4th ed. (2015), Ch. 8, pages 181-241). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a genus of compounds and species which when one of ordinary skill in the art construed the scope of the claims would consider species disclosed in the specification including ones as in the 103 rejection supra and renders the instant claims obvious for the reasons provided above.
Claims 1, 11, 19, 23, 30, 38, 59, 76, and 89-91 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of U.S. Patent No. 11465983 in view of over Burhlane et al. (WO2020086595), Schauer et al. (Sci Rep 10, 5324, 24 March 2020, 15 pages) and Wermuth (“The Practice of Medicinal Chemistry”, 4th ed. (2015), Ch. 8, pages 181-241). Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims a genus of compounds and species which when one of ordinary skill in the art construed the scope of the claims would consider species disclosed in the specification including ones as in the 103 rejection supra and renders the instant claims obvious for the reasons provided above.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
