DETAILED ACTION
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, filed 14 December, 2023, is a national stage application of PCT/GB2022/051846, filed 18 July, 2022, which claims foreign benefit of Application GB2110373.4, filed 19 July, 2021.
Information Disclosure Statement
Two information disclosure statements (IDS) submitted on 14 December, 2023 and 17 October, 2024 are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 14 December, 2023, in the matter of Application N° 18/570,244. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, Claims 1-25 represent all claims currently under consideration.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Objections
Claims 4-25 objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim. See MPEP § 608.01(n).
Additionally, in U.S. practice, dependent claims (e.g., Claims 2-23) typically refer back to a previously recited claim using the definite article (e.g., “The compound of claim 1” versus “A compound”).
For purposes of examination, Claims 4-25 are interpreted as depending directly from Claim 1.
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 10 and 25 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 10 recites “wherein A1, A2, A3 or A4 are selected from” a series of alternatives, which renders it unclear whether the recited selections apply to each of A1-A4 or only to one of those positions. This ambiguity in the selection mechanism obscures the scope of the claimed compound. Additionally, Claim 10 defines multiple alternative structural configurations using subparagraphs (i), (ii), etc., each further limited by provisos specifying allowable heteroatom content. As written, the same ring substitution pattern may satisfy more than one of the recited alternatives, such that the boundaries between the alternatives are unclear and the scope of the claim cannot be readily determined. In view of the ambiguous selection language and the overlapping alternative configurations, Claim 10 fails to distinctly delineate the scope of the claimed compound.
For purposes of examination, Claim 10 is read to encompass any compound in which at least one of A1-A4 satisfies any of the recited alternatives, regardless of whether the same compound may also satisfy another alternative.
Claim 25 attempts to claim a compound as defined in any one of claims 1-23 or a pharmaceutical composition as defined in claim 24, while simultaneously reciting therapeutic uses including “for use in therapy”, “the treatment of cancer,” “the treatment of cancer wherein the compound or pharmaceutical composition is administered in combination with another anticancer agents,” and “the treatment of a triplet repeat disorder.”
As written, Claim 25 improperly mixes statutory categories, combining compound claims, composition claims, and method-of-treatment limitations within a single claim, thereby rendering the scope of the claim unclear.
Additionally, the recited “for use” and “treatment” language fails to positively recite method steps or a definite method of administration, further obscuring whether the claim is directed to a compound, a composition, or a method of treatments.
Furthermore, the parenthetical “(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).
For purposes of examination, Claim 25 is interpreted as directed to a compound as defined in Claim 1, wherein the recited therapeutic language is treated as an intended use that does not further limit the claimed compound.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-5, 7-10, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (WO 2009/060835 A1), hereinafter Kimura, as evidenced by CASPLUS (CAS RN 1151668-01-7.)
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Kimura teaches Methanone, (3,4-dihydro-2(1H)-isoquinolinyl)(2-hydroxy-4,6-dimethoxyphenyl)-(ACI) (CAS RN 1151668-01-7), shown top right, which overlaps the instant Formula I, shown bottom right, wherein A1 is CH, A2 is CH, A3 is CH, A4 is CH (as in instant Claim 10, Y1 is -CH2- (as in instant Claim 7), Y2 is -CH2-CH2- (as in instant Claims 8-9), R2 is H, R4 is H, and R6 is Methyl (as in instant Claims 1-5 and 25), differing only in the para hydroxyl off the phenyl group of the instant genus, which is exemplified as a methoxy in Kimura’s species.
Regarding Claim 24, Kimura teaches the compound of the general formula (I) or a salt thereof can be formulated into a solid preparation such as a tablet, a capsule, a granule, a powder and the like mixed with a pharmaceutically acceptable carrier (‘835, Pg. 36, Para 4 of Description Translation.)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to substitute a methoxy group for a hydroxy group as such substitution on an aromatic ring is a well-known and routine modification in medicinal chemistry. One would have been motivated to make such a substitution as such is commonly employed to modulate polarity, hydrogen-bonding capability, and metabolic stability, while preserving the overall structure and activity of the compound, with a reasonable expectation that the resulting compound would retain similar properties.
Claims 1-5, 7-11, and 16-22 are rejected under 35 U.S.C. 103 as being unpatentable over Thompson (US Patent 9,730,912, published 15 August, 2017, and linked to WO 2008/044054A2, cited in the IDS.)
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Thompson teaches 1,3-Dihydroisoindol-2-yl)(2,4-dihydroxyphenyl)methanone (‘912, Col 149, Example 16), shown top right, which overlaps instant Formula I, shown middle right, wherein A1 is CH, A2 is CH, A3 is CH, A4 is CH (as in instant Claim 10), Y1 is -CH2- (as in instant Claim 7), Y2 is -CH2- (as in instant Claims 8-9), R2 is H, R4 is H (as in instant Claims 1-5), and differing only at the substituent linked to R6.
However, Thompson teaches Formula VIIa (‘912, Col 57), shown bottom right, that expressly limits the substituents at R4a to a closed genus, which consists of hydrogen, fluorine, chlorine, or methoxy.
Although methoxy is not exemplified at that specific position, though is at alternative positions off the phenyl group, it is expressly disclosed as one of only four permitted alternatives. Selection of methoxy from this small, finite set of identified substituents would have been an obvious choice to a person of ordinary skill in the art, as it represents a predictable substitution within the disclosed genus and would have been expected to yield a compound with similar properties. Moreover, methoxy substitution on aromatic rings is well known in medicinal chemistry and is structurally similar to other disclosed substituents, further supporting a reasonable expectation of success. Accordingly, the claimed compound would have been prima facie obvious over the Thompson.
Similarly, Thompson teaches Examples 28, 33, and 34, shown below, which exemplify alternative configurations for instant substituents A1-A4, while maintaining the same core scaffold of Thompson’s Formula VIIa above.
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‘912, Col 159, Example 28
‘912, Col 161, Example 33
‘912, Col 161, Example 34
Example 28 discloses A1 is CR11 wherein R11 is F (as in instant Claim 11) and A4 is CR14 wherein R14 is F (as in instant Claim 21).
Example 33 discloses A2 is CR12 wherein R12 is -(CHRv)d-Z12 wherein d is 0, Z12 is -OR20 wherein R20 is methyl (as in instant Claims 16-17) and A3 is CR13 wherein R13 is Cl (as in instant Claims 19-20)
Example 34 discloses A2 is CR12 and the “-O-CH2-CH2-O-CH3” substituent which can be captured by selections in two branches within the instant Markush:
(a) wherein R12 is an ethoxy substituted with a methoxy (as in instant Claims 16-18), or;
(b) wherein R12 is -(CHRv)d-Z12 wherein d is 0, Z12 is -OR20 wherein R20 is ethyl, and R20 is optionally substituted with Ra, wherein L1 is absent, X1 is -O- and Q1 is methyl (as in instant Claim 22.)
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 1-10, 16-20 and 24-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1, 4-9, 18-20, and 22-24 of U.S. Patent N° 12,552,758.
Although the claims at issue are not identical, they are not patentably distinct from each other because Patent ‘758 discloses and exemplifies at least one compound – (2-benzyloxy-4,6-dihydroxy-phenyl)-(5-bromoisoindolin-2-yl)methanone – (‘758, Claim 22, Example 23), that falls within the scope of the instant claimed Formula I. The instant claims therefore merely recite an overlapping genus encompassing the same subject matter and constitute an obvious variation of the claims of Patent ‘758.
Claim 1-25 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-27 of copending Application N° 18/712,285, Claims 1-25 of copending Application N° 19/148,966, and Claims 1-25 of copending Application N° 19/485,828
Although the claims at issue are not identical, they are not patentably distinct from each other because each of the copending applications claims compounds defined by genus formulas that overlap with or are obvious variants of the instant claimed compounds, including shared core scaffolds and key fixed substituents.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.M.N./Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627