DETAILED ACTION
STATUS OF THE APPLICATION
Receipt is acknowledged of Applicants’ response to the Requirement for Restriction, filed 28 January 2026, in the matter of Application No. 18/181,340. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim 1-5, 8, 16, 22-24, 26-28, 30-35, and 37 are pending
Claims 27-28, 30-33, and 37 have been withdrawn.
Claims 1-5, 8, 16, 22-24, 26-28, 30-31, and 34 have been amended.
Claims 6-7, 9-15, 17-21, 25, 29, 36, and 38 have been cancelled previously.
No claims have been added.
Applicant’s election of Group I (claims 1-5, 8, 16, 22-24, 26, and 34-35), without traverse, is acknowledged.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5, 8, 16, 22-24, 26, and 34-35) in the reply filed on 28 January 2026 is acknowledged.
Claims 27-28, 30-33, and 37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 28 January 2026.
Applicant’s election without traverse of a species in the reply filed on 28 January 2026 is acknowledged. Upon further consideration, the election of species in the requirement for restriction mailed 5 September 2025 is hereby withdrawn.
Thus, claims 1-5, 8, 16, 22-24, 26, and 34-35 are presented and represent all claims currently under consideration.
Priority
The Examiner acknowledges U.S. Provisional Application No. 63/077,245, filed 11 September 2020.
Domestic Priority data as claimed by Applicant:
This application is a CON of PCT/US2021/049905 (09/10/2021)
PCT/US2021/049905 has PRO 63/077,245 (09/11/2020)
Information Disclosure Statement (IDS)
The information disclosure statement (IDS) submitted on 12 November 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Claim Objections
Claim 8 is objected to because of the following informalities:
In line 2, “…each independently H,
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wherein…” should read “…each independently H or
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, wherein…”
In line 3, “…R17 is optionally substituted alkyl, or optionally substituted alkyl;…” should read “…R17 is optionally substituted alkyl;…”
Appropriate correction is required.
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 1-5, 8, 16, 22-24, 26, and 34-35 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 1 recites “Rx and Ry may be taken together to form a double bond with R10, wherein R10 is H or optionally substituted alkyl” in lines 21-22. However, this phrase as written suggests that Rx and Ry could together form a double bond with an H atom (i.e., wherein R10 is H), which is not chemically possible and thus its interpretation is unclear, rendering the instant claim indefinite. Further clarification is required. For the purposes of examination, this phrase will be interpreted as Rx and Ry may be taken together to form a double bond according to -N=C(R)(R’), wherein R or R’ are H or optionally substituted alkyl.
Regarding claims 2-5, 8, 16, 22-24, 26, and 34-35, these dependent claims do not resolve the indefiniteness of claim 1 detailed above.
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.
Claim 22 is 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.
Claim 22 recites the species 51a of the following structure:
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However, this species does not conform with the genus of Formula I on which the instant claim depends. Specifically, the alkylene chain of 51a represented by Q of Formula 1 is 3 carbons, such that R1 must be
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, but it instead indicated as a generic cargo molecule. Thus, species 51a fails to include all the limitations of claim 1 on which the instant claim depends. 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 § 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.
Claims 1-2, 16, 22-24, 26, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2019/089765 A1; IDS of 11-12-2024; hereinafter “Li”).
Regarding claim 1 and claims 2, 16, and 22-23 depending from claim 1, Li teaches synthetic αvβ6 integrin ligands and compositions thereof having serum stability and affinity for integrin αvβ6 and useful for delivering cargo molecules, such as RNAi agents to cells that express integrin αvβ6 (Li; Title; Abstract).
Li further discloses αvβ6 integrin ligands of the Formula IV (Li; claim 4):
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or a pharmaceutically acceptable salt thereof, wherein n is an integer from 1 to 7, and R9 comprises one or more cargo molecules (Li; claim 4). Of particular note, Li discloses structure 6a:
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or a pharmaceutically acceptable salt thereof, wherein X includes a reactive group, a protected reactive group, or a cargo molecule (e.g., an RNAi agent) (Li; claim 7; paragraph [0122]). In addition, Li discloses structure 6.1:
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wherein
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indicates the point of connection to a moiety comprising a cargo molecule (e.g., RNAi agent(s)) (Li; claim 8; paragraph [0125]).
Compounds 6a and 6.1 of Li overlap with the genus of Formula I of instant claim 1 when R1 comprises a cargo molecule; R2-R7 is H; Q is alkylene; X is CR8R9, wherein R8 is taken together with Rx or Ry to form a 6-membered ring, and R9 is H; and Rx and Ry are taken together to form a double bond with X and the atoms to which it is attached to form a 6-membered ring.
In addition, compounds 6a and 6.1 of Li overlap with the genus of Formula Ia of instant claim 2 when R1 comprises a cargo molecule; R2-R7 is H; Q is alkylene; and R18 is optionally substituted alkyl (i.e., a methyl group).
The difference between compounds 6a and 6.1 of Li and the genus of claims 1-2 is that Li does not explicitly teach a species wherein when Q is optionally substituted alkylene and the length of the optionally substituted alkylene chain by represented by Q is 3 carbons, then R1 is
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, as recited in instant claim 1. (Li; paragraph [0271])
However, Formula IV of Li teaches that the alkylene chain corresponding to Q of instant claims 1-2 can be from 1 to 7 carbons (i.e., n is 1 to 7 carbons, Li; claim 4). As such, the skilled artisan could predictably arrive at homologs of compounds 6a and 6.1 of Li that differ in the number of alkylene units corresponding to Q of instant claims 1-2 (i.e, when n is 1-2 or 4-7) with a reasonable expectation of success, and all of these compounds would fully reside within the claimed genus of instant claims 1-2. This difference in the number of methylene (-CH2-) groups can be considered as structurally homologous compounds. MPEP § 2144.09(II) states that “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
In addition, Li also teaches that the variable X in structure 6a can comprise reactive groups, and Li further defines amides as suitable reactive groups for incorporation into the structure (Li; paragraph [0122] and [0271]). Thus, it would have been obvious for the skilled artisan to arrive at compounds of structure 6a wherein X represents amides of
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in a manner consistent with the genus of instant claim 1.
Further regarding claim 22, compound 6a of Li differs from compound 45a of instant claim 22 by a single alkylene carbon atom corresponding to Q of instant claims 1-2. However, the skilled artisan could arrive at the species 45a of instant claim 22 based on Formula IV of Li, which teaches that the alkylene carbon atoms corresponding to Q of instant claims 1-2 can be from 1 to 7 carbon atoms, and the homologous species 6a of Li, because the skilled artisan could reasonably select a 4 carbon chain corresponding to Q as recited in species 45a of instant claim 22 as opposed to the 3 carbon chain of 6a, based on the teachings of Li alone. MPEP § 2144.09(II).
Further regarding claims 16 and 23, compound 6.1 of Li differs from compound 45b of instant claim 23 by a single alkylene carbon atom corresponding to Q of instant claims 1-2. However, the skilled artisan could arrive at the species 45b of instant claim 23 based on Formula IV of Li, which teaches that the alkylene carbon atoms corresponding to Q of instant claims 1-2 can be from 1 to 7 carbon atoms, and the homologous species 6.1 of Li, because the skilled artisan could reasonably select a 4 carbon chain corresponding to Q as recited in species 45b of instant claim 23 as opposed to the 3 carbon chain of 6.1, based on the teachings of Li alone. MPEP § 2144.09(II). Furthermore, compound 6.1 of Li comprises at least one polyethylene glycol (PEG) unit in the attachment comprising the cargo molecule, in a manner consistent with the limitation of R1 in instant claim 16.
The prior art as taught by Li resides in the technical field of integrin αvβ6 ligands directed for use as delivering cargo molecules, such as RNAi agents, in a manner consistent with the instantly claimed invention. Thus, the cited prior art is in the same field of endeavor as the claimed invention, and is therefore deemed analogous art, as described in MPEP § 2141.01(a). As such, one of ordinary skill in the art could predictably arrive at compounds that reside within the genus of instant claims 1-2 based on compounds 6a and 6.1 of Li, and on Formula IV of Li, when n is 1-2 or 4-7 (corresponding to wherein Q of instant claims 1-2 is 1-2 alkylene units or 4-7 alkylene units, respectively). In addition, one of ordinary skill in the art could predictably arrive at species 45a of the claimed invention in a manner consistent with claims 1-2 and 22 by modifying the alkylene chain length of compound 6a of Li from a 3 carbon unit to a 4 carbon unit, and could also predictably arrive at species 45b of the claimed invention in a manner consistent with claims 1-2, 16, and 23 by modifying the alkylene chain length of compound 6.1 of Li from a 3 carbon unit to a 4 carbon unit, respectively, with a reasonable expectation of success. Such an endeavor would result in choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success and would therefore be “obvious to try”, as described in MPEP § 2143(I)(E). Furthermore, the skilled artisan could predictably arrive at the species 45a and 45b of instant claims 22-23 based on compounds 6a and 6.1 of Li because Formula IV of Li teaches a 4 carbon alkylene unit corresponding to these structures, and the skilled artisan could reasonably predict that these homologous compounds would possess similar utility. MPEP § 2144.09(I) states that “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 rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have arrived at compounds corresponding to claims 1-2, 16, and 22-23 based on the teachings of Li.
Regarding claim 24 depending from claim 1, Li teaches wherein the cargo molecule comprises an RNAi agent (Li; claim 11).
Regarding claim 26 depending from claim 24, Li teaches that in some embodiments, a non-nucleotide group is linked to the 5’ end of an RNAi agent sense strand, and an αvβ6 ligand can be linked directly or indirectly to the cargo molecule (Li; paragraph [0303]). Example 15 of Li further teaches the use of RNAi agents including a functionalized amine reactive group (NH2-C6) at the 5’ terminal end of the sense strand to facilitate conjugation to the αvβ6 ligands (Li; Example 15; paragraph [0578]).
Regarding claim 34 depending from claim 1, Li teaches a composition comprising the αvβ6 integrin ligand of claims 1-12 or the structure of any of claims 13-18, and a pharmaceutically acceptable excipient (Li; claim 25).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2019/089765 A1; IDS of 11-12-2024; hereinafter “Li”) as applied to claims 1-2, 16, 22-24, 26, and 34 above, and further in view of Ruminski et al. (US 6,028,223 A; hereinafter “Ruminski”).
Regarding claim 3, claim 1 is rendered obvious over Li as detailed above.
Li fails to teach a compound corresponding to the genus of Formula Ib of instant claim 3.
However, Ruminski teaches a class of compounds or a pharmaceutically acceptable salt thereof, and pharmaceutical compositions thereof and methods of using such compounds and compositions as αvβ3 antagonists (Ruminski; Abstract). Ruminski further teaches that the integrin αvβ3 plays a role in various disease states including tumor metastasis, and antagonists of αvβ3 provide a therapeutic approach for the treatment of neoplasia (inhibition of solid tumor growth) (Ruminski; Col. 1, lines 26-30 and Col. 2, lines 9-12).
Of particular note, Ruminski teaches an integrin ligand of the following structure (Ruminski; Example 37):
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Example 37 of Ruminski overlaps with the genus of Formula Ib of instant claim 3 when R2-R5 and R7 is H; and Q is arylene.
The difference between Example 37 of Ruminski and the genus of claim 3 is that Ruminski does not teach a naphthyl group comprising R1 and R6 or a cargo molecule, and instead teaches a phenyl group at this region of the compound. Furthermore, the claimed genus of Ruminski teaches that this region may comprise a structural variety of substituted and unsubstituted aromatic moieties, including aryl groups that are optionally substituted with fused aryl groups, in a manner consistent with the genus of instant claim 3 (Ruminski; Abstract; claims 1 and 6; Formula I, definition of R1).
However, the naphthyl group comprising R1 and R6 is remedied by the compounds of Li, as detailed in structures 6a and 6.1 above (Li; claims 7-8). Furthermore, Li also teaches examples of integrin ligands comprising a biphenyl nucleus similar to Example 37 of Ruminski, such as structures 14 and 14a:
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wherein structure 14 is linked to one or more cargo molecules (e.g., RNAi agent(s)), and wherein X includes a reactive group, a protected reactive group, or a cargo molecule (Li; paragraphs [0166] and [0168]). Thus, the combined teachings of Li and Ruminski would inform the skilled artisan that compounds comprising a biphenyl nucleus or a naphthyl nucleus would retain activity as integrin ligands, and compounds comprising either a pyridinyl-alkylene group or a guanidinyl-phenylene group would retain activity as integrin ligands, with a reasonable expectation of success.
The prior art as taught by Li and Ruminski reside in the overlapping technical field of compounds targeting integrin receptors, in a manner consistent with the instantly claimed invention. Thus, the cited prior art is in the same field of endeavor as the claimed invention, and is therefore deemed analogous art, as described in MPEP § 2141.01(a). Furthermore, since Li teaches that pyridinyl-alkylene compounds comprising biphenyl or naphthyl groups are competent integrin ligands, and Example 37 of Ruminski teaches a guanidinyl-phenylene containing integrin ligand with a biphenyl group and the genus of Ruminski also includes optionally substituted fused aryl groups, the skilled artisan would be sufficiently motivated to replace the pyridinyl-alkylene group of the compounds 6a and 6.1 of Li with the guanidinyl-phenylene group as taught by Example 37 of Ruminski to pursue a targeted therapy for the treatment of neoplasia with a reasonable expectation of success, as depicted below:
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Such an endeavor would result in the simple substitution of one known element for another to obtain predictable results, as described in MPEP § 2143(I)(B). In addition, the skilled artisan could predictably ascertain that the compounds of Li in view of Ruminski detailed above would maintain affinity for the integrin receptor, since both Ruminski and Li teach structurally similar integrin ligands with utility for cancer therapy. Thus, the skilled artisan could reasonably predict that these compounds would possess similar utility. MPEP § 2144.09(I) states that “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 rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the pyridinyl-alkylene group of Li with the guanidinyl-phenylene group of Ruminski to arrive at compounds that reside within the genus of instant claim 3. The motivation to do so would permit the skilled artisan to pursue, with a reasonable expectation of success, a targeted therapy for the treatment of neoplasia, as described above.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2019/089765 A1; IDS of 11-12-2024; hereinafter “Li”) as applied to claims 1-2, 16, 22-24, 26, and 34 above, and further in view of Schadt et al. (US 2004/0142877 A1; hereinafter “Schadt”).
Regarding claim 4, claim 1 is rendered obvious over Li as detailed above.
Li fails to teach a compound corresponding to the genus of Formula Ic of instant claim 4.
However, Schadt teaches novel biphenyl derivatives of the αvβ6 integrin receptor of formula I:
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in which X is O or S; Y independently of one another are NH, O or S; R1, R1′ and R1″ are H, A, Ar, Het, Hal, NO2, CN, OH, OA, NH2, NHA, NA2, COOH, COOA, CONH2, CONHA or CONA2;
R2 is H, A, alkenyl having from 1 to 8 carbon atoms and from 1 to 2 double bonds, (CH2)mAr, (CH2)mHet, (CH2)mcycloalkyl, (CH2)mCHAAr, (CH2)mCHAHet or (CH2)mCHA-cycloalkyl; A is alkyl having from 1 to 8 carbon atoms; Het is an aromatic monocyclic or bicyclic heterocyclic radical having from 1 to 4 N, O and/or S atoms, which may be unsubstituted or monosubstituted or disubstituted by Hal, A, OH, OA, SA, OCF3, —CO—A, CN, COOA, COOH, CONH2, CONHA, CONA2, NH2, NHA, NA2 and/or NO2; m is 0, 1 or 2; n is 1,2, 3 or 4; and their stereoisomers and their physiologically acceptable salts and solvates (Shadt; Title; Abstract; claim 1). Schadt further teaches that the compounds according to the invention can be used for the prophylaxis and/or therapy of tumours (Schadt; claim 9; paragraph [0235]).
Of particular note, Schadt teaches that a preferred compound of formula I is 3-biphenyl-4-yl-3-[2-(5-ureidopentanoylamino)ethanoylamino]propionic acid (Schadt; paragraph [0144]), which corresponds to the following structure:
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The species of Schadt detailed above overlaps with the genus of Formula Ic of instant claim 4 when R2-R5 and R7 is H; and Q is alkylene.
The difference between the species of Schadt detailed above and the genus of claim 4 is that Schadt does not teach a naphthyl group comprising R1 and R6 or a cargo molecule, and instead teaches a phenyl group at this region of the compound. Furthermore, the claimed genus of Schadt teaches that this region may comprise a structural variety of substituted and unsubstituted aromatic, including aryl groups may comprise naphthyl groups, in a manner consistent with the genus of instant claim 3, (Schadt; claim 1, Formula I; paragraph [0085]).
However, the naphthyl group comprising R1 and R6 is remedied by the compounds of Li, as detailed in structures 6a and 6.1 above (Li; claims 7-8). Furthermore, Li also teaches examples of integrin ligands comprising a biphenyl nucleus similar to the disclosed species of Schadt, such as structures 14 and 14a:
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wherein structure 14 is linked to one or more cargo molecules (e.g., RNAi agent(s)), and wherein X includes a reactive group, a protected reactive group, or a cargo molecule (Li; paragraphs [0166] and [0168]). Thus, the combined teachings of Li and Schadt would inform the skilled artisan that compounds comprising a biphenyl nucleus or a naphthyl nucleus would retain activity as integrin ligands, and compounds comprising either a pyridinyl-alkylene group or a urea-alkylene group would retain activity as integrin ligands, with a reasonable expectation of success.
The prior art as taught by Li and Schadt reside in the overlapping technical field of compounds targeting αvβ6 integrin receptors, in a manner consistent with the instantly claimed invention. Thus, the cited prior art is in the same field of endeavor as the claimed invention, and is therefore deemed analogous art, as described in MPEP § 2141.01(a). Furthermore, since Li teaches that pyridinyl-alkyl compounds comprising biphenyl or naphthyl groups are competent integrin ligands, and the species of Schadt teaches a guanidinyl-phenylene containing integrin ligand with a biphenyl group and the genus of Schadt also includes optionally substituted naphthyl groups, the skilled artisan would be sufficiently motivated to replace the pyridinyl-alkylene group of the compounds 6a and 6.1 of Li with the urea-alkylene group as taught by Schadt to pursue a targeted therapy for the prophylaxis and/or therapy of tumours with a reasonable expectation of success, as depicted below:
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Such an endeavor would result in the simple substitution of one known element for another to obtain predictable results, as described in MPEP § 2143(I)(B). In addition, the skilled artisan could predictably ascertain that the compounds of Li in view of Schadt detailed above would maintain affinity for the integrin receptor, since both Li and Schadt teach structurally similar integrin ligands with utility for cancer therapy. Thus, the skilled artisan could reasonably predict that these compounds would possess similar utility. MPEP § 2144.09(I) states that “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 rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the pyridinyl-alkylene group of Li with the urea-alkylene group of Schadt to arrive at compounds that reside within the genus of instant claim 4. The motivation to do so would permit the skilled artisan to pursue, with a reasonable expectation of success, a targeted therapy for the prophylaxis and/or therapy of tumours, as described above
Claims 5 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2019/089765 A1; IDS of 11-12-2024; hereinafter “Li”) as applied to claims 1-2, 16, 22-24, 26, and 34 above, and further in view of Hölzemann et al. (US 6,576,637 B1; IDS of 11-12-2024; hereinafter “Hölzemann”).
Regarding claim 5, claim 1 is rendered obvious over Li as detailed above.
Li fails to teach a compound corresponding to the genus of Formula Id of instant claim 5.
However, Hölzemann teaches β-alanine derivatives of formula I:
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in which Q1, Q2, Q3 or Q4 is, in each case, independently of one another, CH or N, with the sum of N atoms in the ring being not more than 4; R1 is H, A, Ar, Hal, OH, OA, CF3 or OCF3; R2 is H or A;
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R4 and R5 are, in each case, independently of one another, H, A, Hal, OH, OA, CF3, OCF3, CN, NH2, NHA, NA2 or NH—C(O)A; R6 is H, A, —(CH2)m—OH, —(CH2)m—O—C(O)A or —(CH2)m—Ar; A is alkyl with 1 or 6 C atoms; Ar is unsubstituted or mono-, di or trisubstituted aryl; Hal is F, C1, Br or I; n is 2, 3, 4, 5 or 6; m is 1, 2, 3 or 4; or a physiologically acceptable salt or solvate thereof (Hölzemann, claim 1). Hölzemann further teaches that these compounds are integrin inhibitors, including αvβ6 integrin, that can be used for the treatment of a variety of conditions including tumors, with cancer therapy being a preferred use (Hölzemann; Abstract; Col. 1, lines 63-65; Col. 3, lines 47-78).
Of particular note, Hölzemann discloses the species 3-{2-[5-(pyrimidin-2-ylamino)pentanoylamino]acetylamino}-3-(4-biphenylyl)propionic acid, 3-{2-[4-(4-methylpyridin-2-ylamino)butyrylamino]acetylamino}-3-(4-biphenylyl)propionic acid, and 3-(4-naphthalen-2-ylphenyl)-3-{2-[5-(4-methylpyridin-2-ylamino)pentanoylamino]acetylamino}propionic acid (Hölzemann; Col. 11, lines 36-37 and 40-41; Example 19):
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Based on the overlapping structural features and similar utility of these species as integrin inhibitors as detailed by Hölzemann and shown above, the skilled artisan would predictably recognize that the pyridine/pyrimidine substructures and the biphenyl/naphthyl substructures are interchangeable, such that the skilled artisan could arrive at the following species based on the teachings of Hölzemann alone with a reasonable expectation of success (see MPEP § 2144.09(I)):
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This species detailed above overlaps with the genus of Formula Id of instant claim 5 when R2-R7 and R18 is a methyl group; and Q is alkylene.
The difference between the species of Hölzemann detailed above and the genus of claim 1 5 is that Hölzemann does not teach a naphthyl group comprising R1, as defined in instant claim 5.
However, this deficiency is adequately remedied by Li, who teaches naphthyl group comprising R1 as detailed in structures 6a and 6.1 above (Li; claims 7-8). Thus, the combined teachings of Li and Schadt would inform the skilled artisan that compounds comprising a methylpyridine or a methylpyrimidine would retain activity as integrin ligands with a reasonable expectation of success.
The prior art as taught by Li and Hölzemann reside in the overlapping technical field of compounds targeting integrin receptors, including αvβ6 receptors, in a manner consistent with the instantly claimed invention. Thus, the cited prior art is in the same field of endeavor as the claimed invention, and is therefore deemed analogous art, as described in MPEP § 2141.01(a). Furthermore, since Li teaches that methylpyridine-alkylene compounds are competent αvβ6 integrin ligands, and the species of Hölzemann teaches that methylpyrimidine-alkylene compounds are competent αvβ6 integrin ligands, the skilled artisan would be sufficiently motivated to replace the methylpyridine-alkylene group of the compounds 6a and 6.1 of Li with the methylpyrimidine-alkylene group as taught by Hölzemann to pursue a targeted therapy for the treatment of tumors with a reasonable expectation of success, as depicted below:
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Such an endeavor would result in the simple substitution of one known element for another to obtain predictable results, as described in MPEP § 2143(I)(B). In addition, the skilled artisan could predictably ascertain that the compounds of Li in view of Hölzemann detailed above would maintain affinity for the integrin receptor, since both Li and Hölzemann teach structurally similar integrin ligands with utility for cancer therapy. Thus, the skilled artisan could reasonably predict that these compounds would possess similar utility. MPEP § 2144.09(I) states that “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 rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).” Finally, the species rendered obvious over Li in view of Hölzemann as detailed above corresponds to compound 55a of instant claim 22 (when X is a cargo molecule) and compound 55b of claim 23 (when X is 4 polyethylene glycol units that is further linked to a cargo molecule), respectively.
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have replaced the methylpyridine-alkylene group of Li with the methylpyrimidine-alkylene group of Hölzemann to arrive at the invention of instant claims 5 and 22-23. The motivation to do so would permit the skilled artisan to pursue, with a reasonable expectation of success, a targeted therapy for tumors, as described above.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (WO 2019/089765 A1; IDS of 11-12-2024; hereinafter “Li”) as applied to claims 1-2, 16, 22-24, 26, and 34 above, and further in view of Khan et al. (“Silencing Myostatin Using Cholesterol-conjugated siRNAs Induces Muscle Growth”; Mol. Ther. Nucleic Acids, 2016, 5, e342, pages 1-9; hereinafter “Khan”) as evidenced by Ducceschi et al. (“Post-transcriptional regulation of ITGB6 protein levels in damaged skeletal muscle”; J. Mol. Histol. 2014, 45, 329-336; hereinafter “Ducceschi”).
Regarding claim 35, claim 34 is rendered obvious over Li, as detailed above.
Although Li teaches a composition, wherein the αvβ6 integrin ligand is directly or indirectly conjugated to an RNA strand of the RNAi agent and is capable of inhibiting the expression of a target gene in an epithelial cell or in a bronchiolar epithelial cell (Li; claims 27-28; paragraph [0303]), Li fails to explicitly teach wherein the cargo molecule is an RNAi agent targeting a gene located in a skeletal muscle cell, as recited in instant claim 35.
However, Khan teaches a method of gene silencing using cholesterol-conjugated short interfering RNAs (siRNAs) to induce muscle growth, wherein a single cholesterol moiety is linked to the end of the RNA strand (Khan; Title; Abstract; page 7, Col. 1, paragraph 2). Khan further teaches a mouse model study wherein the systemic delivery of a chemically modified cholesterol-conjugated siRNA targeting the muscle-specific gene myostatin (Mstn) resulted in 85-95% knockdown in skeletal muscle and >65% reduction in circulating Mstn protein sustained for >21 days (Khan; Abstract). The siRNA platform of Khan could have major implications for treatment of a variety of muscle disorders, including muscular atrophic diseases, muscular dystrophy, and type II diabetes (Khan; Abstract).
Furthermore, although αvβ6 integrin is typically associated with epithelial expression, it has been shown that this receptor is expressed in skeletal muscle as a result of injury, including in a genetic model of Duchenne Muscular Dystrophy, as evidenced by Ducceschi (Abstract; page 330; Col. 1, paragraphs 1-3; page 332; Col. 2, paragraph 1; page 333; Col. 1, paragraph 1).
The prior art as taught by Li and Khan reside in the overlapping technical field of RNAi-derived compositions for therapeutics. In addition, both Li and Khan teach the use of RNAi agents wherein small molecules (i.e., integrin ligands or cholesterol) are bonded to the RNA strand. Thus, the cited prior art is in the same field of endeavor as the claimed invention, and is therefore deemed analogous art, as described in MPEP § 2141.01(a). Furthermore, the supporting teachings of Ducceschi indicate to the skilled artisan that injured skeletal muscle expresses the integrin receptor αvβ6, which is the target for the ligands of Li. As such, the skilled artisan would be sufficiently motivated to substitute the RNAi agent of Li with the skeletal-muscle targeting RNAi agent of Khan as evidenced by Ducceschi to arrive at an RNAi-based therapy that targets the muscle-specific gene myostatin to pursue a therapeutic treatment for muscle disorders, such as muscular dystrophy, with a reasonable expectation of success. Such an endeavor would result in the simple substitution of one known element for another to obtain predictable results, as described in MPEP § 2143(I)(B).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the RNAi agent of Li with the RNAi agent of Khan as evidenced by Ducceschi to arrive at a composition wherein the cargo molecule is an RNAi agent targeting a gene located in a skeletal muscle cell. The motivation to do so would permit the skilled artisan to pursue, with a reasonable expectation of success, a therapeutic treatment for a variety of muscle disorders, including muscular atrophic diseases and muscular dystrophy, as described above.
Free of the Prior Art
Claim 8 is not subjected to a prior art rejection and is free from the prior art.
The closest prior art to the claimed invention is Li. Although Li renders obvious the invention of claim 1, as detailed above, Li fails to teach a compound according to claim 1, wherein Q is
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, wherein R15 and R16 are each independently H or
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, wherein R17 is optionally substituted alkyl, and n is an integer from 1 to 10, as recited in instant claim 8. This deficiency is not sufficiently remedied by the teachings Ruminski, Schadt, or Hölzemann, either alone or in combination, and as such one of ordinary skill in the art would not have arrived at this claim limitation based on the cited prior art detailed above. Therefore, claim 8 is distinguished from the prior art for the reasons set forth above.
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 1-5, 8, 16, 23-24, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, and 28-30 of copending Application No. 18/181,335.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-5, 8, 16, 23, claim 1 of copending Application No. 18/181,335 teaches a delivery platform comprising an RNAi agent and a targeting ligand, wherein the RNAi agent is covalently linked to the targeting ligand. Of particular note, claim 7 of copending Application No. 18/181,335 discloses compounds 41b-42b and 44b-60b that are identical to the compounds of 41b-42b and 44b-60b of instant claim 23 and therefore these species anticipate instant claim 23 and the genus of Formula I of instant claim 1 on which the instant claim depends.
Further regarding instant claim 16, all of these compounds 41b-42b and 44b-60b disclosed in claim 7 of copending Application No. 18/181,335 possess at least one polyethylene glycol unit, and therefore teach the limitation of instant claim 16.
Further regarding instant claim 2, species 45b-46b, 49b-54b, and 56b-60b disclosed in claim 7 of copending Application No. 18/181,335 anticipate Formula Ia of instant claim 2.
Further regarding instant claim 3, species 42b and 44b disclosed in claim 7 of copending Application No. 18/181,335 anticipate Formula Ib of instant claim 3.
Further regarding instant claim 4, species 47b-48b disclosed in claim 7 of copending Application No. 18/181,335 anticipate Formula Ic of instant claim 4.
Further regarding instant claim 5, species 55b disclosed in claim 7 of copending Application No. 18/181,335 anticipates Formula Id of instant claim 5.
Further regarding instant claim 8, species 44b and 47b-50b disclosed in claim 7 of copending Application No. 18/181,335 teach every limitation of the instant claim.
Regarding instant claim 24, claim 1 of copending Application No. 18/181,335 teaches a delivery platform comprising an RNAi agent and a targeting ligand, wherein the RNAi agent is covalently linked to the targeting ligand.
Regarding instant claim 34, claims 29-30 of copending Application No. 18/181,335 teach a composition comprising the claimed delivery platform and a pharmaceutical excipient.
Regarding instant claim 35, claim 28 of copending Application No. 18/181,335 teaches wherein the RNAi agent inhibits the expression of the mRNA of a human gene in a skeletal muscle cell.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 8, 16, 23-24, 26, and 34-35 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 13, 15, 41-42, and 50 of copending Application No. 19/120,297.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1-5, 8, 16, 23, claims 1 and 11 of copending Application No. 19/120,297 teaches an RNAi agent linked to a targeting ligand. Of particular note, claim 15 of copending Application No. 19/120,297 discloses compounds 41b-42b and 44b-60b that are identical to the compounds of 41b-42b and 44b-60b of instant claim 23 and therefore these species anticipate instant claim 23 and the genus of Formula I of instant claim 1 on which the instant claim depends.
Further regarding instant claim 16, all of these compounds 41b-42b and 44b-60b disclosed in claim 15 of copending Application No. 19/120,297 possess at least one polyethylene glycol unit, and therefore teach the limitation of instant claim 16.
Further regarding instant claim 2, species 45b-46b, 49b-54b, and 56b-60b disclosed in claim 15 of copending Application No. 19/120,297 anticipate Formula Ia of instant claim 2.
Further regarding instant claim 3, species 42b and 44b disclosed in claim 15 of copending Application No. 19/120,297 anticipate Formula Ib of instant claim 3.
Further regarding instant claim 4, species 47b-48b disclosed in claim 15 of copending Application No. 19/120,297 anticipate Formula Ic of instant claim 4.
Further regarding instant claim 5, species 55b disclosed in claim 15 of copending Application No. 19/120,297 anticipates Formula Id of instant claim 5.
Further regarding instant claim 8, species 44b and 47b-50b disclosed in claim 15 of copending Application No. 19/120,297 teach every limitation of the instant claim.
Regarding instant claim 24, claims 1 and 11 of copending Application No. 19/120,297 teaches an RNAi agent linked to the claimed targeting ligands.
Regarding instant claim 26, claim 13 of copending Application No. 19/120,297 teaches an RNAi agent wherein the targeting ligand is linked to the 5’ terminal end of the sense strand.
Regarding instant claim 34, claim 41 of copending Application No. 19/120,297 teaches a pharmaceutical composition comprising the claimed RNAi agent linked to a targeting ligand and a pharmaceutical excipient.
Regarding instant claim 35, claim 42 of copending Application No. 19/120,297 teaches a method comprising introducing an effective amount pharmaceutical composition comprising the claimed RNAi agent for inhibiting expression of a DMPK gene in a cell, and claim 50 of copending Application No. 19/120,297 teaches wherein the DMPK gene expression is reduced in one or more of paraspinal, facial, torso, abdominal, and limb muscle tissues of the subject.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 16, 22-24 and 34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-6, and 13 of U.S. Patent No. 11,597,701 B2.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim 1 and claims 2, 16, and 22-23 depending from claim 1, claim 1 of U.S. Patent No. 11,597,701 B2 teaches an αvβ6 integrin ligand having the structure:
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or a pharmaceutically acceptable salt thereof, wherein X comprises a cargo molecule
In addition, claim 2 of U.S. Patent No. 11,597,701 B2 discloses the following αvβ6 integrin ligand:
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wherein
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indicates the point of connection to a moiety comprising a cargo molecule.
Compounds 6a and 6.1 of U.S. Patent No. 11,597,701 B2 overlap with the genus of Formula I of instant claim 1 when R1 comprises a cargo molecule; R2-R7 is H; Q is alkylene; X is CR8R9, wherein R8 is taken together with Rx or Ry to form a 6-membered ring, and R9 is H; and Rx and Ry are taken together to form a double bond with X and the atoms to which it is attached to form a 6-membered ring.
In addition, compounds 6a and 6.1 of U.S. Patent No. 11,597,701 B2 overlap with the genus of Formula Ia of instant claim 2 when R1 comprises a cargo molecule; R2-R7 is H; Q is alkylene; and R18 is optionally substituted alkyl (i.e., a methyl group).
The difference between compounds 6a and 6.1 of U.S. Patent No. 11,597,701 B2 and the genus of claims 1-2 is that U.S. Patent No. 11,597,701 B2 does not explicitly teach a species wherein when Q is optionally substituted alkylene and the length of the optionally substituted alkylene chain by represented by Q is 3 carbons, then R1 is
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, as recited in instant claim 1.
However, the skilled artisan could predictably arrive at homologs of compounds 6a and 6.1 of U.S. Patent No. 11,597,701 B2 that differ in the number of alkylene units corresponding to Q of instant claims 1-2 with a reasonable expectation of success. This difference in the number of methylene (-CH2-) groups can be considered as structurally homologous compounds. MPEP § 2144.09(II) states that “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In reWilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977).”
Further regarding claim 22, compound 6a of U.S. Patent No. 11,597,701 B2 differs from compound 45a of instant claim 22 by a single alkylene carbon atom corresponding to Q of instant claims 1-2. However, the skilled artisan could arrive at the species 45a of instant claim 22 based on the teachings of U.S. Patent No. 11,597,701 B2, because the skilled artisan could reasonably select a 4 carbon chain corresponding to Q as recited in species 45a of instant claim 22 as opposed to the 3 carbon chain of 6a, based on the teachings of U.S. Patent No. 11,597,701 B2 alone. MPEP § 2144.09(II).
Further regarding claims 16 and 23, compound 6.1 of U.S. Patent No. 11,597,701 B2 differs from compound 45b of instant claim 23 by a single alkylene carbon atom corresponding to Q of instant claims 1-2. However, the skilled artisan could arrive at the species 45b of instant claim 23 based on the teachings of U.S. Patent No. 11,597,701 B2, because the skilled artisan could reasonably select a 4 carbon chain corresponding to Q as recited in species 45b of instant claim 23 as opposed to the 3 carbon chain of 6.1, based on the teachings of U.S. Patent No. 11,597,701 B2. MPEP § 2144.09(II). Furthermore, compound 6.1 of U.S. Patent No. 11,597,701 B2 comprises at least one polyethylene glycol (PEG) unit in the attachment comprising the cargo molecule, and claim 6 of U.S. Patent No. 11,597,701 B2 teaches the claimed compounds further comprising a polyethylene glycol linker having 2-20 ethylene oxide units, in a manner consistent with the limitation of R1 in instant claim 16.
The prior art as taught by U.S. Patent No. 11,597,701 B2 resides in the technical field of integrin αvβ6 ligands directed for use as delivering cargo molecules, such as RNAi agents, in a manner consistent with the instantly claimed invention. Thus, the cited prior art is in the same field of endeavor as the claimed invention, and is therefore deemed analogous art, as described in MPEP § 2141.01(a). As such, one of ordinary skill in the art could predictably arrive at compounds that reside within the genus of instant claims 1-2 based on compounds 6a and 6.1 of U.S. Patent No. 11,597,701 B2. In addition, the skilled artisan could predictably arrive at the species 45a and 45b of instant claims 1-2, 16, and 22-23 based on compounds 6a and 6.1 of U.S. Patent No. 11,597,701 B2 because the skilled artisan could reasonably predict that these homologous compounds would possess similar utility. MPEP § 2144.09(I) states that “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 rePayne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).”
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to have arrived at compounds corresponding to claims 1-2, 16, and 22-23 based on the teachings of U.S. Patent No. 11,597,701 B2.
Regarding claim 24 depending from claim 1, claim 5 of U.S. Patent No. 11,597,701 B2 teaches wherein the cargo molecule comprises an RNAi agent.
Regarding claim 34 depending from claim 1, claim 13 of U.S. Patent No. 11,597,701 B2 teaches a composition comprising the αvβ6 integrin ligand and a pharmaceutically acceptable excipient.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Derek Rhoades whose telephone number is (703)-756-5321. The Examiner can normally be reached Monday–Thursday, 7:30 am–5:00 pm EST; Friday, 7:30 am–4:00 pm EST.
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/D.R./Examiner, Art Unit 1692
/AMY C BONAPARTE/Primary Examiner, Art Unit 1692
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