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
Election/Restriction
In the reply to Restriction Requirement mailed on 03/06/2026, Applicant cancelled all claims 29-48 dated 10/23/2023 and add new claims 49-67 on 05/01/2026.
Applicant elected, with traverse, Group I invention, and species having following structure , in the reply filed on 05/01/2026.
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Applicant argues new claims 65-67 directed to product and use of said product have unity and different from Buckl (WO 2020/180768 A1).
Applicant’s argument is fully considered but not persuasive. Please note Applicant cannot cancel all the claims which lack unity “a priori” and argues new claims against Buckl on the record.
More importantly, instant claimed PROTAC bifunctional compounds comprising vast variety of S, L, E moiety and combination thereof do not share significant common structure element. The common structure of S6’ and S6’’’ is
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which was already taught by Buckl (See Table A ). The alleged technical feature of inhibiting SOS1 associated with S moiety was also taught by Buckl . There is no special technical features associated with the general inventive concept, thus, the requirement for unity of invention is not met. The requirement is still deemed proper and therefore made FINAL.
New claims 65-67 (Group II), drawn to a method for treating SOS1 mediated disease, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Instant elected species, Example 3 (as disclosed in [1561]) , is a compound of Formula I, wherein: (1) S is S6’
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(3) E is E21-1h.
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Claims 49-64 read on the elected species.
The elected species, Example 3, is not entered into STN database. The search has been expanded to non-elected species wherein S moiety is
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E moiety is
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, and linker moiety comprising combination of
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, are rejected under following 103 rejection. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species. It should be noted that the prior art search/examination will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reconsidered. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reconsideration that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Status of Claims
Claims 49-67 are pending in instant application.
Claims 65-67 are withdrawn.
Claims 49-64 are currently under examination.
Priority
Instant application 18/556,862, filed on October 23,2023, is a national stage of international Application No. PCT/CN2022/088560, filed April 22, 2022, which claims the benefit of Chinese Application No. 202110443693.1, filed April 23, 2021 and Chinese Application No. 202210201700.1, filed March 2, 2022.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy of Chinese Application Nos 202110443693.1 and 202210201700.1 in Chinese are filed on 10/23/2023. No English translation is included in the certified copy of foreign Application Nos 202110443693.1 and 202210201700.1. Applicant’s right of foreign priority is not perfected due to lack of English translation thereof. Further, instant elected species is NOT disclosed in Chinese Application No. CN202110443693.1.
Information Disclosure Statement
The information disclosure statements 02/08/2024, 01/29/2025, 10/31/2025, 06/02/2026 are in compliance with the provisions of 37 CFR1.97. Accordingly, the reference listed in IDS are being considered by the examiner. Reference written in foreign language is considered to the degree of English abstract or patent family of foreign patent.
Claim Objections
Claims 49-64 are objected to because of the following informalities:
Claim 49 recites compound of formula I and/or a stereoisomer, an enantiomer, a diastereomer, a deuteride, a hydrate, a solvate and/or a pharmaceutically acceptable salt thereof. Claims 50-64 recite the compound of formula I and/or the stereoisomer, the enantiomer, the diastereomer, the deuteride, the hydrate, the solvate and/or the pharmaceutically acceptable salt thereof. The stereoisomer is broad range of limitation including enantiomer and diastereomer, thus, separate recitation of enantiomer and diastereomer is repetitive and not necessary. The multiple article “a” and “the” are repetitive. For clarity, “and/or” should be “or”.
Claim 64 recites “according to any one of claims 49” , which should read according claim 49.
Please note instant bifunctional compounds of formula I comprising vast variety of subgroup and moieties with similar detonation, e.g. S6, S6’, S6’’’, S6c, S6c’’, X’, X’’, X’’’, LA, L, etc.. The lengthy claims have not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any typo errors of which applicant may become aware in the claim.
Specification-Abstract
There are typos in the abstract, e.g. “Disclosed are an SOS1 degrading agent”.
Applicant is reminded of the proper content of an abstract of the disclosure.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl urea, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its chemical class. Correction is required. See MPEP § 608.01(b).
Specification
Specification dated 10/23/2023 recites reference to prior application. “claiming the benefit of Chinese Application No. 202110443693.1, filed April 23, 2021 and Chinese Application No. 202210201700.1, filed May 2, 2022”. There is typo for the filing date of Chinese Application No. 202210201700.1 which is filed on March 2, 2022, NOT May 2, 2022.
Instant specification disclosed vast variety of compounds having complex chemical names and structure thereof. The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Improper Markush Grouping
Claims 49 and 54-56 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use that flows from the substantial structural feature.
Claim 49 recites Formula I comprising vast variety of subgenus alternatives of binding moiety linker, degron moieties, and/or combination thereof, wherein the Markush grouping embraces different chemical species that don’t belong to the same recognized chemical class and/or do not share substantial structural similarity. It’s noted ring A, B, C, X’’, X’’’, L3, could be bond or variety of groups, e.g. S(O), S(O2)-, etc. such that instant claimed LA moiety
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comprising combination of ring A, B, C, X’’, X’’’ and L3 do not share substantial structural similarity.
Instant claims 54-56 recite linker moiety comprising variety of subgroups further substituted with different groups and combination thereof, wherein the combination of linker groups do not belong to the same recognized chemical class and/or share substantial structural feature, e.g.
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.
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Since there is only minimal structure similarity to the Markush alternative of compound of Formula I, one can conclude that the instantly claimed compounds are substantially structurally different. Further, there is no common uses that flow from the shared structure features. Instant claimed compound species exhibit variety of inhibitory activity in 3D cell proliferation assay of different KRAS mutant human cell , ranging from <=50nM to >=100nM, to not detected (See instant Table 1), which further attest common use is not fully established from the shared minimal common structure.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 49-61 and 64 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the full-scope of claimed compound of Formula I. This is a written description rejection, rather than an enablement rejection under 35 U.S.C. 112, first paragraph. Applicant is directed to the MPEP 2163 and Guidelines for the Examination of Patent Applications Under the 35 U.S.C. 112, 1st "Written Description" Requirement, Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001.
MPEP 2163.02 states “ Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, the inventor was in possession of the invention, and that the invention, in that context, is whatever is now claimed.”
Independent claim 49 drawn to compound of formula I comprising vast varieties of SOS1 binding moieties, linker moieties and E3 ubiquitin binding moieties further substituted with multiple R groups. Dependent claims 54-57 further limit to improper Markush group of linker moiety. The Applicant is required to provide adequate written description and evidence of possession of the claimed genus, compound of Formula I and subgenus that align with the instantly claimed broad scope.
MPEP 2163 II states; “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above)”. While applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. “A representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” MPEP 2163 II.
As elaborated in preceding Improper Markush grouping, instant claimed bifunctional compounds comprising vast variety of protein binding moieties, linker moieties and degron moieties and combination thereof, embraces vast variety of chemical species that don’t do not share substantial structural similarity. There is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus” MPEP 2163 II.
It’s noted instant specification discloses/testes about 79 compounds (See Table 1 ). However, the disclosed compounds species are not representative for the full scope of compound of Formula I. The disclosure of other moieties/groups, in addition to the species reduced to practice, is in the form of general formula with lists of possible groups, e.g. X’’ or X’’’ is
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. This kind of disclosure is not representation of any species. A "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species. MPEP 2163.1.A. and Fujikawa v. Wattanasin, 93 ”.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed.Cir. 1996). For example, there are no embodiments/working example comprising S(O) , S(O2) or C(O)O, etc. as X’’ or X”’, or ring A, B, C substituted with F in the linker moiety.
There are substantial structural variation in the genus/subgenus embraced by instant claims which scope is not fully supported by instant disclosure. For chemical application wherein there is high unpredictability in preparation, one of skill in the art would not recognize from the disclosure that the applicant was in possession of full scope of compound of Formula I. The specification does not clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed.
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.
Claim 49-61 and 64 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.
Independent claim 49 recites bifunctional group comprising S-L-E,
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The definition of R groups is for S6 or S6’, However, there is no definition and/or structure for S6 moiety, Thus, there is insufficient antecedent basis for S6 moiety. The definition of S6’’’ is unclear and indefinite because there is no definition of R groups for S6’’’. It’s not clear how X-S6’ or X-S6’’’ is attached to L moiety and the attaching point of X to S6’ or S6’’’ is not clear.
Claims 50-61 and 64 are rejected due to dependency on claim 49.
Claim 51 is drawn to limitation of
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fragment in S moiety and /or R3 is hydrogen; and/or R7 is methyl. It’s not clear if the limitation
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is required in claim 51 since R3 is hydrogen as recited in claim 49.
Claim 54 recites vast variety of linker moiety comprising variety of X’’ and X’’’. Claim 54 recites
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for LA2, LA3, LA4 (See page 7, page 8 and page 9 of claim). However, there is no recitation of X’ in linker moieties, LA2, LA3 and LA4, Thus, there is insufficient antecedent basis for recitation of X’ moiety.
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and the linker moiety of instant claims is indefinite.
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 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 49-64 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. ( WO2022061348 A1, Applicant’s IDS dated 02/08/2024), in view of Arista et al. (WO 2021053495 A1, Applicant’s IDS dated 06/02/2026 ).
Regarding bifunctional degrader targeting at SOS1 protein (son of sevenless homolog 1) , Chan teaches compound of Formula I to XV, or an enantiomer, solvate, hydrate, pharmaceutically acceptable salt thereof and pharmaceutical composition thereof, comprising SOS1 protein binding moiety, linker moiety (L) and ubiquitin ligase-binding moiety RE, as modulators of SOS1 protein through SOS1 degradation /inhibition for treating disease/disorder mediated by SOS1 or Ras (e.g. cancer, etc.) (See abstract; page 2, [0007]-[0082], [00110], Examples A1 to A70, claims 1-159).
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Regarding instant claimed SOS1 binding moiety as recited in instant claims 50-53, Chan teaches variety of embodiments as SOS1 binding moiety (See [00110]-[00116]),
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It’s noted formula XXIV-b of Chan read on the S moiety of instant elected species and instant claims 50-53.
Regarding linker moieties recited in instant claims 54-57, Chan teaches embodiments comprising variety of linker group and combination thereof ( See [0276]- [00305]),
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It’s noted RL read on instant ring A, B, C and ZL read on instant X’’ and X’’’.
Chan teaches embodiments comprising 3,9-diazaspiro[5.5]undecane
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etc. that read on instant recited ring A, B, C, and combination thereof, e.g.
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(See [00297]-[00298], [00302]-[00305]).
Regarding instant claims 58-61, Chan teaches embodiments comprising variety of RE as CRBN E3 binding moiety, e.g. EC-I, EC-II, etc. ( See [00120]-[00123], [00159], [00165]),
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Chan teaches bifunctional compound specie comprising SOS1 binding moiety and linker moiety that are similar to instant claimed moiety, e.g. A33, A44, A68, etc.
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Regarding claim 64, Chan teaches pharmaceutical composition comprising compound of formula I and a pharmaceutically acceptable excipient (See [0008],[00320]-, claims 141-145).
The difference of Chan compound and instant claimed compound is the combination of linker moiety and the ubiquitin ligase-binding moiety.
Arista teaches bifunctional compound of Formula I, or pharmaceutically acceptable salt thereof, comprising various protein binding moiety, linker moiety (L) and ubiquitin ligase-binding moiety for treating disease/disorder mediated by various target proteins (e.g. cancer, etc.) (See abstract; page 2, lines 11-26; claims 1-209),
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Arista teaches variety of Targeting Ligase Binder, e.g. TLB-I to TLB-IX, etc. (See page 2, line 22 to page 8, lines 1-13)
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It’s noted targeting ligase binder TLB-IX, wherein Rd6 is H, halogen, C1-6 alkyl, C1-6 alkoxyl, etc. read on instant E moiety recited in instant claims 58-61.
Arista teaches variety of Linker moiety ( See page 8, lines 14 to 27 )
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Arista teaches linker moiety that are similar to instantly claimed linker moiety (See page 9, lines 10-17),
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Arista also teaches Targeting Ligase Binder-Linker, e.g. TLB-L-I to TLB-L-IX (See page 10, lines 17-22 to page 24, lines 1-10),
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(See page 28, line 5).
Arista teaches various embodiment comprising targeting ligase binder-Linker that read on instant E moiety and very similar to instant linker moiety (See page 301, 302, etc.)
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Arista teaches bifunctional compound BF-IV, BF-V-A, BF-V-B, etc. comprising the targeting ligand, the linker moiety and the targeting ligase binder (See page 29, lines 3-23; page 30, lines 12-22; page 31, lines 1-26),
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Arista teaches various targeting ligand, e.g. ARAF, BRAF, KRAS, KRAS G12V/C/D etc. (See Table 1 starting form page 34). It’s noted the targeting ligand KRAS read on instant SOS1 which is associated/interacted with KRAS pathway.
It would have been prima facie obvious to one of ordinary skilled in the art before the effective filing date of instant application to explore more SOS1 modulator/inhibitor comprising SOS1 binding moiety, linker moiety and ULM moiety, based on combined teachings of Chan and Arista, together with optimization based on general knowledge of structure similarity and bioisosteric modification for SAR study of bifunctional degraders, and arrive at instantly claimed invention with reasonable expectation of success. At the time of instant invention was made, it was already known that bifunctional SOS1 modulator comprising SOS binding moiety, linker moiety, ULM moiety targeting at SOS1 degradation , e.g.
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could be made as taught by Chan. Arista further teaches variety of ubiquitin binding moiety, linker groups and combination thereof, e.g.
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that could combine with various targeting ligand, including KRAS that is associated with SOS1.
According to M.P.E.P. § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). A skilled artisan would be motivated to further explore more bifunctional SOS1 modulators based on combined teachings of Chan and Arista, and reasonably expect further exploration/ optimization together with general knowledge of structure similarity and bioisosteric modification would provide more alternative bifunctional compounds as SOS1/KRAS modulator. The exploration of different linker moiety and attachment for the targeting ligand moiety and ULM moiety based on general knowledge of structural similarity and bioisosteric modification are within the knowledge of ordinary skilled in the art as illustrated in Chan and Arista.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity/ bioisosteric modification and proteasome-mediated degradation of targeting protein. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
Claim 49-64 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 47, 53-66 of copending Application No. 18/556/867 in view of Chan et al. ( WO2022061348 A1). This is a provisional nonstatutory double patenting rejection.
Reference claims are directed to bifunctional compounds S-L-E wherein the linker moiety and E moiety recite the same or similar groups. For example,
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Reference claim 62 recite compound species that are similar to instant claim 62, except the S moiety.
The collective teaching of Chan is elaborated in preceding 103 rejection and applied as before. Chan teaches bifunctional compound of Formula I to XV, or pharmaceutically acceptable salt thereof and pharmaceutical composition thereof. Chan teaches SOS1 binding moiety that read on instant S moiety, for example,
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According to M.P.E.P. § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. It would have been prima facie obvious to one of ordinary skilled in the art to explore more SOS1 modulator/inhibitor based on combined teachings of reference claims and Chan, and arrive at instantly claimed invention with reasonable expectation of success.
For example, the compound species in reference claim 62, could have been modified by the S moiety taught by Chan and arrived at instant claimed compound species and deuteride thereof.
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Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIYUAN MOU whose telephone number is (571)270-1791. The examiner can normally be reached Mon-Fri 9:00-5:30.
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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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/LIYUAN MOU/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
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