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 .
DETAILED ACTION
Status of the Claims
Claims 43-63 are pending. Claims 45, 47-49 and 51-63 are withdrawn. Claims 43-44, 46 and 50 are rejected.
Election/Restrictions
Applicant's election of Group I (claims 43-50) and of the elected species compound 111,
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153
285
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, without traverse in the reply filed on 11/10/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 43-44, 46 and 50 read on Applicant’s species election of compound 111. Examination of the elected invention was conducted in accordance with the MPEP 803.02.
The elected species is allowable in view of the prior art; therefore, examination of the Markush-type claim has been extended to the scope of formula (I) wherein, Ring A is phenyl substituted with one R3 wherein R3 is methyl; Ring B is unsubstituted phenyl; R1, R2, R4, R20 and R40 are each H; R5 is methyl; R6 is H; and R60 is H or methyl.
Since art was found on a nonelected species, subject matter not embraced by the above-identified non-elected species is therefore withdrawn from further consideration. Claims 45, 47-49 and 51-63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant is reminded that upon the cancellation of claims to a non-elected invention, the inventorship must be amended in compliance with 37 CFR 1.48(b) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. Any amendment of inventorship must be accompanied by a request under 37 CFR 1.48(b) and by the fee required under 37 CFR 1.17(i).
Priority
This application is a 35 U.S.C. 371 National Stage Filing of International Application No. PCT/IL2021/050541 filed 05/12/2021, which claims priority under 35 U.S.C. 119(a-d) to PCTIL2020050524 filed 05/14/2020. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d), which papers have been placed of record in the file.
Information Disclosure Statement
The information disclosure statement(s) (IDS) dated 05/07/2025 has been considered.
Claim Objections
Claim 1 is objected to because of the following informalities:
page 48, paragraph beginning with “R3 is” should have “or” between the last two items of the list; and
page 49, first paragraph should have “or” between the last two items of the list.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 43-44, 46 and 50 are rejected under 35 U.S.C. 112(b) 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.
Regarding claims 43-44 and 46, the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Applicant may overcome the rejection by deleting each instance of a parenthetical “e.g.” in the claims.
Dependent claim 50 is rejected as indefinite for the same reason since it does not correct the indefiniteness issue of their parent claims.
Claims 43 and 46 contain the trademark/trade name PROTAC. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe heterobifunctional small molecules and/or proteolysis-targeting chimeras and, accordingly, the identification/description is indefinite.
Dependent claims 44 and 50 are rejected as indefinite for the same reason since they do not correct the indefiniteness issue of their parent claims.
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 43-44 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Creuzberg et al in DD 140966, as cited in the IDS dated 05/07/2025, as evidenced by CAS Registry entry 77048-95-4 and CAS Registry entry 77048-67-0.
Creuzberg et al. teach compound 99
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112
175
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(see Table 1, page 16) which has the structure
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245
536
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and anticipates a compound of instant formula I of claim 43,
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191
479
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wherein:
Rings A and B are each phenyl;
R1, R2, R4, R6, R20 and R40 are each H; and
R3 is CH3, which is an isotopic variant of CD3, and l is 1; and
R5 and R60 are each CH3.
See also claim 44 and Formula (II), for instance, wherein each of X1, X2, X3, X4, and X5 are C.
Creuzberg et al. also teach compound 65 (see Table 1, page 15) which has the structure
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232
572
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and anticipates a tautomer of the compound of instant formula I of claim 43,
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191
479
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wherein:
Rings A and B are each phenyl;
R1, R2, R4, R6, R20 and R40 are each H; and
R3 is CH3, which is an isotopic variant of CD3, and l is 1;
R5 is CH3; and
R60 is H when the prior art compound tautomerizes.
Regarding instant claim 50, drawn to a pharmaceutical composition comprising a compound of formula (I) and a pharmaceutically acceptable carrier, the CAS Registry 77048-95-4 and CAS Registry 77048-67-0 entry documents include predicted properties including bioconcentration factors at varying pH values. See section at the bottom of the first page. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015).
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable excipient. Therefore, claim 50 is anticipated by the prior art.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 43-44, 46 and 50 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 46-65 of copending Application No. 19/321,644 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claim 47 of the copending claims disclose compounds 248 and 249,
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249
505
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, which are embraced by instant formula (I) of instant claim 43,
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190
483
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, wherein:
Ring A and Ring B are each substituted phenyl;
R1, R2, R20 are either H, C1alkoxy, or substituted C5 heterocyclic ring;
R3 is C3 haloalkyl and l is 1;
R4 and R40 are each H;
R5 is methyl; and
R6 is H.
See also claim 44 and Formula (II), for instance, wherein each of X1, X2, X3, X4, and X5 are C. Moreover, reference compounds 248 and 249 are identical to compounds 101 and 100 of instant claim 46, respectively.
Regarding instant claim 50 drawn to a pharmaceutical composition comprising a compound of claim 43, reference claim 65 is drawn to the same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jalisa H. Ferguson whose telephone number is (703)756-1489. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on (571) 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.H.F./Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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