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 .
Information Disclosure Statement
Four information disclosure statement (IDS) submitted: one on 06/05/2023; one on 08/26/2024; one on 02/12/2026; and one on 06/05/2026. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892 or were cited in the IDS, they have not been considered.
Nucleotide and/or Amino Acid Sequence Disclosures
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
The Specification discloses nucleotide/peptide sequences on pages 16, 37 and 127-128.
For compliance with sequence rules, it is necessary to include the sequence in the “Sequence Listing” and identify them with SEQ ID NO. In general, any sequence that is disclosed and/or claimed as a string of particular bases or amino acids, and that otherwise meets the criteria of CFR 1.821(a), must be set forth in the “Sequence Listing.” See MPEP 2422.03.
While the Examiner has made every attempt to check the Specification for sequence compliance, Applicant is required to carefully check the entire Specification for any and all issues regarding sequence compliance.
For the response to this Office Action to be complete, Applicant is REQUIRED to comply with the Requirements for Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Failure to comply with the Requirements will be considered nonresponsive.
Specification
The disclosure is objected to because of the following informalities: page 52, 6th line from bottom, one of the Greek characters was not rendered and appears as a square.
Appropriate correction is required.
The use of the term ORENCIATM, Herceptin, Kadcyla (appears in Drawings also), and other trade names or marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the terms.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
While the Examiner has made every attempt to check the Specification for trade mark use compliance, Applicant is required to carefully check the entire Specification for any and all issues regarding trade mark use compliance.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (page 184 – Bargh et al. reference). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Drawings
The drawings are objected to because they contain trade names Kadcyla® and Enhertu® not properly referenced with the “®” symbol – see objection to spec. for trade name or mark use compliance guidance.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Status of the Claims
Claims 1-25 are pending in this application.
Claim Objections
Claim 16 is objected to because of the following informalities: Claim 16 contains a peptide sequence but no sequence ID.
Appropriate correction is required.
Examiner Notes
Claims 8, 17, 19, and 21 are free of the prior art but stand rejected/ objected over formal matters.
Duplicate Claims Warning
Applicant is advised that should claim 18 be found allowable, claim 24 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Applicant is advised that a recitation of the intended use of the claimed invention, such as the use of the conjugate of claim 18 for the manufacture of a medicament in the instant application, must result in a structural difference. Note: MPEP 2111.02. In the present case, both claims are directed to the conjugates of claim 18.
Claim Interpretation
Regarding claims 1, 2, 4-5, 11, 15-16, and 18, the specification provides no definition for the term “derived from”. For the purposes of applying art, this term will be interpreted as encompassing moieties that one of ordinary skill in the art would envision as being synthesizable from the sources specified in the claims (e.g. natural amino acids, unnatural amino acids, etc.).
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 1-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 1 recites the broad recitation “a triazole moiety” – which encompasses all triazole isomers and substitution patterns, and the claim also recites “(
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)” which is the narrower statement of the range/limitation. Similarly, the claim recites “a urea moiety” which broadly encompasses substituted and unsubstituted ureas, then the claim states “(-NH-C(O)-NH-)” which is the narrower limitation. Examiner suggests deleting parentheses and information therein.
Claim 2 recites the broad recitation “a cancer-specific peptide ligand” and “a human fibronectin …peptide” and “a PD-1/PD-L1 interaction inhibitor”, and the claim also recites “(AGM-330)” and “(“APTEDB”)” and “(“BMS-1166”)”, respectively, which are the narrower statements of the range/limitation. Examiner suggests deleting parentheses and information therein.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 2-16, 18-20, and 22-25 are rejected for depending upon the limitations of claim 1.
Claim 17 recites the limitation "compounds 1-36." There is insufficient antecedent basis for this limitation in the claims. Applicant is advised, as stated in MPEP 2173.05(s), claims should be complete to themselves and the reference to tables in the specification renders the claims incomplete.
Claim 19 recites the limitation "the ligand-PD conjugate of claim 17". There is insufficient antecedent basis for this limitation in the claim. For the purposes of applying art, it will be assumed Applicant intended: “A ligand-PD conjugate comprising a ligand moiety and a moiety derived from a compound of claim 17…”
Regarding claim 20, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 21 recites the limitation "conjugates 1-28." There is insufficient antecedent basis for this limitation in the claim. Applicant is advised, as stated in MPEP 2173.05(s), claims should be complete to themselves and the reference to tables renders the claims incomplete.
Further regarding claim 21, while compounds 1-18 are found in the spec, and limitations from the spec. should not be read into the claims, for the purposes of compact prosecution, Applicant is advised that some conjugate compounds in claim 21 contain the trademark/trade name Herceptin®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 9-11, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1626359-65-6 CAS Registry File Accessed May 25th, 2026 from STN, entered into STN Sep. 25th, 2014.
Regarding claims 1-2, 9, 11, and 15, the compound below anticipates the instant claims when instant n2 and n3 are 0; D is derived from mertansine; L1 is a maleimide (a bifunctional crosslinker containing a coupling moiety capable of reacting with a ligand) or
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(anticipating claim 9 when nL1 is 2); M is
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or
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or
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(a multifunctional moiety); L2 is
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(bifunctional crosslinker bonded to PD via amide bond) or
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(anticipating claim 10); wherein PD is Pcn5 – L3n6 – D, wherein Pc is
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(L3 is absent and Pc Is bonded to D via a stable bond - disulfide bond; this group may be derived from cysteine – a natural amino acid – thus anticipating claims 2 and 11 – see claim interpretation of “derived” in 112(b)).
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Claims 1, 4, 6-7, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 2098985-02-3 CAS Registry File Accessed May 25th, 2026 from STN, entered into STN Jun. 25th, 2017.
Regarding claims 1, 4, 6-7, 15, the compound below the instant claims when D is derived from mertansine; L3 is a stable bond (
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); Pc is absent; L2 is an amide bond (
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); M is
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(anticipating claim 6 when Mn1 complex contains
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); HP is PEG-NH2; and L1 is -OH.
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Regarding claim 13, the compound above anticipates the instant claim when HP is
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, wherein Lp is a linker group (amide) and Cap is an alkyl-amino group, which could react with an ST molecule.
Claims 1, 3-5, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1907647-51-1 CAS Registry File Accessed May 25th, 2026 from STN, entered into STN May 10th, 2016.
Regarding claims 1, 3-5, 15, the compound below anticipates the instant claims when D is derived from mertansine; L1 is
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(amino – anticipating claim 2) (capable of reacting with formyl in the ligand); M is the multifunctional linker complex
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or
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(which contains the moiety
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- anticipating claim 6; and derived from an amino acid – claim 4; and may be derived from a diamine dicarboxylic acids – claim 5); L2 is
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(bifunctional crosslinker) or
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; n5 and n5’ can be 0; and L3 and L3’ can be the bifunctional linker
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.
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Claims 1, 15, 18, 20, and 22-25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tan et al. (Bioconjugate Chem. 2020, 31, 1766−1774) (“Tan”).
Regarding claims 1, 15, 18, and 24, Tan discloses their compound DM1-SMCC and complex HApDC below (Figure S1). DM1-SMCC anticipates the instant compounds of Formula I when L1 is a bifunctional group containing a hydroxy succinimide moiety; M is
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or
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; L2 is
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or
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, bonded to PD via amide bond; and n5 and n6 are 0. Further regarding claim 18, the bond is formed with the amino functional group of the ligand and the L1 of Formula I. Further regarding claim 24, Tan discloses their compounds for the treatment of cancer.
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Regarding claim 20, this structure above shows a 1:1 ratio of “ligand” to “compound”.
Regarding claim 22, Tan discloses administration of HApDC to mice (page. 1772, col. 2, 2nd to last para.).
Regarding claim 23, Tan discloses their HApDC compound in a PBS buffer solution (page 1772).
Regarding claim 25, Tan discloses a method for preparing their conjugate (see Figure S1) wherein their ligand is reacted with a compound of Formula I.
Claims 1-6, 9-11, 13-15, 18, 20, and 22-25 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zhao et al. (WO 2020/257998 A1) (“Zhao”).
Regarding claims 1-6, 9-11, and 13-15, Zhao discloses the compounds 247 (page 251), 265 (page 257), 273 (page 260), and 131 (page 279), below. These compounds anticipate the instant claims when D is derived from SN38 or mertansine (in 131) bound to L3 via a C-O “stable bond”; L1 is derived from maleimide
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or
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; M is, for example,
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(in 265) – derived from amino acids or
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- derived from a diamino dicarboxylic acid (claims 4-5); L2 is
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, wherein nL2 is 0 (as in 247 and 273); Pc (in 265) is
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- derived from an amino acid (claim 11) or
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; HP (in 247) is
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(anticipating claims 13-14) or
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(in 131); and L3 is
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.
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Regarding claim 3, Zhao discloses their compound 265 above, which anticipates the instant claims wherein there is a PD2 group on M; wherein D’ is SN38; Pc’ is
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or
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; and L3’ is
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.
Regarding claim 18, Zhao discloses their conjugate compound C-238 (page 377) below – formed via a covalent bond between L1 and a sulfhydryl.
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Regarding claim 20, Zhao discloses a 7.6 molar ratio between the drug and the ligand, anticipating the instant claims (see Table 1, page 285).
Regarding claim 23, Zhao discloses their compound C-238 in PBS buffer vehicle (page 286).
Regarding claim 22, Zhao discloses intravenous administration of their compound C-238 to mice with cancer (page 286).
Regarding claim 24, Zhao discloses their compounds as medicaments for cancer treatment.
Regarding claim 25, Zhao discloses a method for preparing conjugate C-238 (page 281, line 12).
Claims 1-2, 4, 11, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Calvaresi et al. (Chem. Sci., 2013, 4, 2319 – Cited in IDS) (“Calvaresi”).
Regarding claims 1-2, 4, 11, and 16, Calvaresi discloses the compound EC-145 (Fig. 2) below, which anticipates the instant claims when D is derived from vinblastine; L1 is
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or -NH2; M is
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(derived from amino acids); ST is derived from folic acid; L2 is
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; Pc is
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(derived from amino acid); L3 is
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.
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Claim Rejections - 35 USC § 103
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.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (WO 2020/257998 A1) (“Zhao”); as applied to claims 1-6, 9-11, 13-15, 18, 20, and 22-25.
The teachings of Zhao are disclosed above and incorporated herein.
Regarding instant claim 12, Zhao discloses their conjugate compounds of Formula I below, wherein T is an antibody (ligand – as referenced in instant claim 18) and the rest of the compound corresponds to the instant compounds of Formula I. Zhao discloses definitions of L1-2 (page 18) – including peptides, amino acids, etc. (corresponding to instant L3 and M); W is a self-immolative spacer like peptidyl, hydrazone, disulfide, etc. (corresponding to L3 linkage to D); V1-2 are spacers comprising natural or unnatural amino acids, heterocycles, peptides, etc. (corresponding to instant L1 and L2-Pcn5) (see page 19); Q1-2 are independently Formula I-q1 (corresponding to instant HP), wherein G1-2 are defined in page 5, starting line 20 - -OC(O)-, -CH2-, -NH-, etc.; X1-2 are defined in page 20, line 1; Y2 is defined starting on line 26; D is a cytotoxic agent; p1-3 are independently 0-100, but not all 0 at the same time; q1-2 are 0-24. In page 22, Zhao states X1-4 and Y1-3 can be absent or present or be -OC(O)-, -OC(O)NH-etc.
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Zhao discloses their conjugate compounds wherein W and L1 (corresponding to instant L3) may be:
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and
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(page 55), reading on instant L3 being
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and
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, respectively. Zhao also discloses their V1 (corresponding to instant L2-Pcn5), may contain
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;
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; etc. wherein m may be 0-20 and R5, 5’ may be H (page 58-59); reading on instant Pc being
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and
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, respectively. While Zhao discloses an extremely broad genus of compounds, their genus encompasses the instant invention.
Therefore, one having ordinary skill in the art would have found the claimed compounds prima facie obvious, since they are generically embraced by Zhao’s disclosed formula; In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). See MPEP 2144.08. The requisite motivation for arriving at the claimed compounds stems from the fact that they fall within the generic class of compounds for the preparation of conjugates that serve as anti-cancer therapeutics, as disclosed by Zhao. Accordingly, one having ordinary skill in the art would have been motivated to prepare any of the compounds embraced by the disclosed generic formula, including those encompassed by the claims.
Applicant is advised, a novel useful compound that is isomeric with the prior art compound is unpatentable unless it possesses some unobvious or unexpected beneficial property not possessed by the prior art compound. In re Norris, 179 F.2d. 970, 84 USPQ 458 (CCPA 1970). Therefore, it would have been obvious to one of ordinary skill to expect similar properties of structurally similar compounds since they are suggestive of one another. It has been held that a compound, which is structurally isomeric with a compound of the prior art, is prima facie obvious absent unexpected results. In re Finely, 81 USPQ 383 (CCPA 1949); 84 USPQ 458 (CCPA 1950).
Furthermore, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zhao et al. (WO 2020/257998 A1) (“Zhao”); as applied to claims 1-6, 9-12, 13-15, 18, 20, and 22-25; in view of Calvaresi et al. (Chem. Sci., 2013, 4, 2319 – Cited in IDS) (“Calvaresi”).
The teachings of Zhao are disclosed in the 102 and 103 sections above and incorporated herein.
Zhao teaches their Q1-2 are independently Formula I-q1 (corresponding to instant HP-ST – see examples Iq-22 and Iq-25 below – page 21). Zhao also teaches their L1-2 and V1-2 may contain
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or
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, etc. (page 59).
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While Zhao doesn’t specifically disclose the incorporation of glucose as a “secondary targeting molecule”; the teachings of Calvaresi are relied upon for these disclosures.
Calvaresi teaches that glycoconjugation is a promising strategy for targeting cancers (abstract). Calvaresi discloses which positions of glucose can be substituted for the desired effect (section 4-a, col. 1, page 2327). For example, Calvaresi discloses a docetaxel-glucose conjugate, wherein the glucose is bound to a carboxylic acid to form a ester moiety (Fig 4b).
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320
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Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare Zhao’s compounds, for example compound 131 as shown below, wherein there is a secondary target attached to an HP moiety. One of ordinary skill would have been motivated to do so because Zhao discloses their compounds, specifically here compound 131; and further because Calvaresi teaches glycoconjugation is a promising strategy for targeting cancers, thus allowing for targeted delivery of drug payload into the cancer. One of ordinary skill would have had a reasonable expectation of success because Zhao discloses all their compounds and methods of making; further because Calvaresi discloses which positions of glucose can be substituted for the desired effect.
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Conclusion
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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