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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/10/2026 has been entered.
Current Status
This action is responsive to the amended claims of 03/10/2026. Claims 1-3,18,47,72,86,100,114-115,136-137,142,156,159,172,176-179,182,184-185,189-190,194-195,200-201,207-210, and 228 are pending. Claims 3,86,115,182,184-185,189-190,194-195,200-201, and 207-209 are withdrawn.
Claims 1-2, 18, 47, 72, 100, 114, 136-137, 142, 156, 159, 172, 176-179, 210, and 228 have been examined on the merits
Election/Restrictions
The amendments of 03/10/2026 have overcome the previous prior art rejections.
A search for the compound of claim 1 (and dependent claims 47, 72, 136, 142, 156, 159, 172, and 176-179) did not return any prior art. A search for the compounds of independent claims 210 and 228 did not return any prior art. A search for the compound of Formula (I) wherein the TLB is TLB-III (claims 18, 100, and 114) did not return any prior art. See SEARCH 6 of the attached search notes.
The search was extended to the following species:
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wherein the TLB is TLB-I, Ring A is 5-membered heteroaryl with 0 Rd4 or 2 Rd4 which are H, Rd1 and Rd2 are each H, Rd3 is H, Rd5 is H, m is 1 or 2, n is 1; the linker is a bond; and the TL is a methyl linked to the TLB by the Linker. Since this search has art, per Markush search practice, the search will not be unnecessarily extended to further species in this action. The species reads on claims 2 and 137.
Claims 3, 86, and 115 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of Formula (I), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/27/2024.
Claims 182, 184-185, 189-190, 194-195, 200-201, and 207-209 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/27/2024.
To expedite prosecution: Applicant is asked to cancel claims 189-190,194-195, 200-201, and 207-209 since they are drawn to distinct compositions of matter which are not eligible for rejoinder. See MPEP 821.04.
Priority
The effective filing date remains 09/16/2019.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/10/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Examiner acknowledges receipt of and has reviewed the amendments and remarks of 03/10/2026; no new matter is found.
The 112(a) rejection of claims 1, 3, 47, 65, 72, 136, 142, 156, 159, 172, and 178-179 is withdrawn since Applicant has structurally defined the TL and linker in these claims.
The 112(b) rejection of claim 3 is withdrawn since the claim now depends from claim 2.
The 112(b) rejection of claims 72 and 136 is withdrawn since parent claim 1 now recites and defines "-X1-L2-X2-”.
The 112(b) rejection of claim 156 is withdrawn since parent claim 1 now recites and defines variables L1, X1, L2, X2, and L3 and claim 156 recites and defines U.
The 112(b) rejection of claim 159 is withdrawn since parent claim 1 now recites and defines variables L1, L2, and L3.
The 112(b) rejection of claim 172 is withdrawn since parent claim 1 now recites and defines "L1-X1-L2-X2- L3”.
The 112(d) rejection of claims 3, 72, 136, 156, 159, and 172 is withdrawn for the same reasons the 112(b) rejections of the same claims were withdrawn.
The 102(a)(1) rejection of claims 1, 3, 47, 65, 72, 136, 142, 156, 159, 172, 176-179, and 228 over BUCKLEY evidenced by HAN is withdrawn since the claims are no longer drawn to produgs.
The 102(a)(2) rejection of claims 1, 3, 47, 65, 72, 136, 142, 156, 159, 172, 177-179, and 228 over ARISTA is withdrawn since claim 1 has been amended to exclude wherein L3 is C(O) when the TL is TL-1. Further, the compound of ARISTA differs from compound 24 of independent claim 228 by the attachment point of the linker to the TLB. Thus, the compound of ARISTA does not read on the instant claims.
The 102(a)(2) rejection of claims 1, 3, 47, 65, 72, 136, 142, 156, 159, 172, 177-179, and 228 over NOVARTIS evidenced by HAN is withdrawn since: 1) the claims are no longer drawn to prodrugs and 2) the TL differs from instant TL-5 at the annotated N
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which is not found in instant TL-5.
The anticipatory nonstatutory double patenting rejection of claims 1, 3, 47, 65, 72, 142, 156, 159, 177-179, and 228 over claims 1-13 of U.S. Patent No. 11,541,056, evidenced by HAN is withdrawn. The amendments to claim 1 no longer overlap with the species recited in the reference patent; i.e., the reference TL is none of the instant TLs.
The anticipatory nonstatutory double patenting rejection of claims 1, 3, 47, 65, 72, 136, 142, 156, 159, 172, 177-179, and 228 over claims 1-14 of U.S. Patent No. 11,613,543 is withdrawn. The amendments to claim 1 no longer overlap with the species recited in the reference patent; i.e., the reference linker comprises L3 as C(O) when the TL is TL-1. Further, the compound 8 differs from the instant species of claim 228 in the attachment point of the linker to the TLB.
The anticipatory nonstatutory double patenting rejection of claims 1, 3, 47, 65, 72, 136, 142, 156, 159, 172, 176, and 178 over claims 1, 6, 9, 11, 14-16, and 26 of Application No. 17/020,114 is withdrawn. The reference application has been abandoned.
Response to Amendments
Claim Rejections - 35 USC § 112 – necessitated by amendment
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 2, 18, 100, 114, 137, and 210 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 claimed invention. This is a written description rejection.
MPEP 2163(I) states “The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant [inventor] has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee [inventor] was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.”
Factors to be considered in making the determination as to whether one skilled in the art would recognize that the applicant was in possession of the claimed invention as a whole at the time of filing include: (a) Actual reduction to practice; (b) Disclosure of drawings or structural chemical formulas; (c) Sufficient relevant identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below.
The Instant Disclosure:
Claim 2 is very broadly drawn to bifunctional compounds of Formula (I) consisting of a Targeting Ligand (TL), a Linker, and a Targeting Ligase Binder (TLB) of Formula TLB-I. The TL is only defined as “capable” of binding a Target Protein and the Linker is only defined as covalently linking the TL to the TLB. Only the TLB has structural limitations. Further, the claim is drawn to “prodrugs” thereof which are not structurally defined.
Claims 18 and 137 do not provide any structural limitations for the TL and Linker. Claims 100 and 114 provide structural limitations to the Linker, but do not provide any structural limitations to the TL. Each of these claims is also drawn to a “prodrug” of Formula (I) and/or a prodrug of the TLB with no structural limitations. Claim 210 structurally defines a full compound of Formula (II) (a subgenus of Formula (I)); however, it is also drawn to a “prodrug” thereof with no structural limitations. This lack of structural definition does not allow the artisan to envisage the compounds which are part of the invention (see Factors (b) and (c) above).
Moreover, the claimed compounds are expected to have pharmacological utility: binding a target protein and Cereblon. The lack of structural definition regarding the TL and/or prodrug does not provide guidance for which chemical moieties would impart the proper mechanism of action to the bifunctional compound.
The specification only teaches the artisan how to make a small fraction of the bifunctional compounds encompassed by Formula (I). The specification provides methods of making, starting Pg. 172, for bifunctional compounds with specific structural elements. For example, Scheme 1 requires the Linker to contain a nitrogen-containing heterocyclyl at X1 and a -CHO moiety on the TL (Pg. 173). Schemes 1-21 (Pg. 173-205) all provide synthetic methods for bifunctional compounds of varying structures; however, these schemes do not provide examples across the entire breadth of the bifunctional compound of Formula (I), in particular the TL. Furthermore, the specification does not define the term “prodrug” and does not provide any specific examples of such compound. Thus, Factors (a) and (d), above, are not met.
MPEP 2163(II)(A)(2) states “The disclosure of an element may be critical where those of ordinary skill in the art would require it to understand that inventor was in possession of the invention… Amgen, Inc. v. Chugai Pharm.Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) ("it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it").” After review of the specification and claims, the claimed TL and prodrugs are not defined in a way that distinguishes them from other materials. Moreover, the generic “Targeting Ligand” and “prodrug” would encompass compounds which have not yet been discovered and/or those with uncharacterized metabolic pathways.
Level of Skill and Knowledge in the Art:
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a synthetic chemist and/or health practitioner with several years of professional experience. This factor is outweighed, however, by the unpredictable nature of the pharmaceutical art. Each embodiment of the invention is required to be individually assessed for physiological activity by in vitro or in vivo screening to determine which compounds exhibit the desired pharmacological activity (e.g. the ability to bind to both a target protein and a target ligase).
Regarding the TL, CHURCHER (Churcher, I., J. Med. Chem., 2017, 61, 444-452; provided 03/07/2025) states: “Identifying an agent with high potency and selectivity to modulate a biological target or process is not always straightforward, even for well described classes of proteins. This challenge may become more acute as greater genomic knowledge highlights new, less well characterized targets for drug intervention which often lack high affinity ligand binding sites.” (Pg. 444 Left Col. Para 2). CHURCHER further discloses “any drug intervention to subvert the endogenous protein regulation machinery to remove a specific protein requires a high degree of design and specificity to mediate a number of biological steps, a significant challenge.” (Pg. 446 Left Col. Para 3).
The challenges cited in CHURCHER are particularly relevant to the instant claims as the TL and Target Protein are left structurally undefined in the claims. Thus, Factors (e) and (f) are not met.
Regarding the prodrug, HAN (Han, H., AAPS PharmsciTech., 2000, 2, 1-11; provided 012/10/2025) describes that some prodrug forms are not chemically or structurally related to their active form, for example, both glucose
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and hypoxanthine
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are prodrug forms of hydrogen peroxide
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(Pg. 5 Table 1). In view of HAN and the open-ended nature of “prodrug” as defined by the instant disclosure, the artisan would not have sufficient guidance as to what a “prodrug” of Formula (I) encompasses. Thus, Factors (e) and (f) are not met.
Conclusions:
Due to the breadth of genus Formula (I) TL defined only by function, the lack of guidance in the claims/specification regarding embodiments of the full scope of Formula (I) and “prodrug” thereof, and the challenges in the art, the artisan would not be able to immediately envisage the breadth of bifunctional compounds encompassed by the scope of Formula (I), particularly the TL, and any “prodrug” thereof.
Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to the artisan that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention. Thus, claims 2, 18, 100, 114, 137, and 210 are rejected as lacking written description for the full scope of bifunctional compound and “prodrug” thereof.
To overcome this rejection: Applicants are encouraged to bring structural limitations for the TL into claim 2 and to strike “prodrug” from the claims. Note, withdrawn claims 86 and 115 would be similarly rejected if not withdrawn.
To expedite prosecution: withdrawn claims 184-185 also recite “prodrug” and would be subject to a similar rejection under a future rejoinder. Please strike “prodrug” from all pending claims.
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 72, 100, 114, 137, 176-177, and 210 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 72 recites the linker is "substituted with 0-4 occurrences of Rb" and further defines Rb. There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 does not define the linker as comprising further substituents, such as Rb. Thus, linkers substituted by Rb are not within the scope of claim 1. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 100 recites Rd4 is "C1-6alkoxyalkyl". There is insufficient antecedent basis for this limitation in the claim. Parent claim 2 recites Rd4 is "C1-6alkoxy". The addition of “alkyl” to the end of the moiety in claim 100 can be interpreted as adding on an additional alkyl to the C1-6alkoxy; this is outside of the scope of claim 2. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 114 recites variables L1, L2, and L3 are part of the Linker; however, the claim does not define these variables. Thus, the chemical identities of these moieties are unclear. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 137 recites variable L1 with no context as to what part of the compound of parent claim 2 is being further defined. There is insufficient antecedent basis for this limitation in the claim. Claim 2 does not recite an L1 and claim 137 does not provide a structure containing L1. Thus, L1 is outside of the scope of claim 2. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 176 recites the TL is of Formula (BRD9-I). There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 defines the TL as chosen from TL-1, TL-2, TL-3, TL-4, or TL-5. The structures of TL-1 – TL-5 do not overlap with the structure of BRD9-I. Thus, the TL BRD9-I is not within the scope of the parent claim. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 177 recites the TL is of Formula (BTK-I). There is insufficient antecedent basis for this limitation in the claim. Parent claim 1 defines the TL as chosen from TL-1 – TL-5. The structure of BTK-I is broader in scope than the most similar TL: TL-1. Thus, the TL BTK-I is not within the scope of the parent claim. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
Claim 210 recites “n” in the structure of Formula (II), “the Targeting Ligand” under L1, and “Formula (BF-II)” under L3. The variable “n” is not defined in the text, leaving the chemical structure undefined. Further, there is not mention of a “Targeting Ligand” or any mention of/structure given for “Formula (BF-II)”; thus, these moieties are unclear. Therefore, the metes and bounds of the claim are undefined rendering the claim indefinite.
To expedite prosecution, please address these issues with withdrawn claims 86, 115, and 182:
Claims 86 and 115: R’ is not defined in either claim or parent claim 2.
Claim 182: 1) claim 182 recites “The method of any one of claim 1, wherein inhibiting, reducing, or eliminating the activity of a Target Protein,” however, claim 1 is not a method claim; 2) use of “e.g.,” and parentheses around limitations “(e.g., Cereblon E3 Ubiquitin ligase)” is unclear.
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.
Claims 72, 100, 137, and 176-177 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. Each of the claims 72, 100, 137, and 176-177 recite limitations outside of the scope of their parent claims, described in ¶30-31 and 33-35 above. Therefore, none of these claims properly further limit their respective parent claims. 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.
Claim Rejections - 35 USC § 102 – necessitated by amendment
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 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.
Claims 2 and 137 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MAINOLFI (WO 2019/140387, pub. 18 July 2019; cited IDS of 02/10/2023) as evidenced by LEUNG (Leung, C.S. et al., Journal of Medicinal Chemistry, 2012, 55, 4489-4500).
MAINOLFI teaches compound I-26
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(Pg. 59 Table). This compound falls under instant Formula (I)
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wherein the Targeting Ligase Binder (TLB) is TLB-I
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, Ring A is 5-membered heteroaryl with 0 Rd4 or 2 Rd4 which are H, Rd1 and Rd2 are each H, Rd3 is H, Rd5 is H, m is 1 or 2, n is 1; the Linker is a bond; and the Targeting Ligand (TL) is a methyl linked to the TLB by the Linker.
Since both the Linker and TL are left structurally undefined in claims 2 and 137, the bond and methyl are understood to fall within the broad categories: the Linker covalently links the TL and TLB; and the TL is a group capable of binding to a Target Protein. As evidenced by LEUNG, methyl groups are important to modulating biological activity of small molecule ligands in their binding of proteins, with methyl groups often boosting activity (Pg. 4489 Abstract & Introduction). Thus, Examiner understands methyl groups are “capable” of binding a target protein.
Further, since the variable L1 of claim 137 is unclear, Examiner interprets L1 as the Targeting Ligand wherein L1 is a C1 alkylene.
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)(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 2 and 137 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by MAINOLFI (WO 2019/140387, effectively filed 14 Jan. 2019; cited IDS of 02/10/2023) as evidenced by LEUNG (Leung, C.S. et al., Journal of Medicinal Chemistry, 2012, 55, 4489-4500).
The teachings of MAINOLFI are above. No priority document is cited since the international filing date is used as the effectively filed date.
Conclusion
Claims 2, 18, 72, 100, 114, 137, 176-177, and 210 are rejected.
Claims 1, 47, 136, 142, 156, 159, 172, 178-179, and 228 are allowable.
The following is an examiner’s statement of finding of allowable subject matter: claims 1, 18, 47, 72, 100, 114, 136, 142, 156, 159, 172, 176-179, 210, and 228 are free of the art. The close art is ARISTA (WO 2019/186343, effectively filed 22 March 2019; cited IDS of 05/10/2023).
ARISTA teaches compound 8
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(Pg. 103 Line 25) wherein: the TLB is of Formula TLB-VI wherein A is phenyl, Rd6 is methoxy, Rd7 is H, Rd8 is H, and m and n are both 1 and the TL is TL-1. However, the linker differs from instant claim 1 wherein L3 is not C(O) when the TL is TL-1 and ARISTA does not teach any species having an L3 as recited in instant claim 1. Further, the TLB does not read on the instantly claimed TLB-I or TLB-III. Finally, while compound 8 is close to the instant compound 24 (see claim 228), the attachment point of the linker to the TLB differs:
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the instant L3 is para to the dihydrouracil while ARISTA is meta. Thus, ARISTA does not teach or suggest the compounds of instant claims 1, 18, 47, 72, 100, 114, 136, 142, 156, 159, 172, 176-179, 210, and 228.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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