DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application, filed September 9, 2025, is a continuation of 18/020221, filed February 7, 2023, which is a national stage application of PCT/US21/45100, filed August 6, 2021, and claims the benefit of U.S. provisional application 63062814, filed August 7, 2020.
Status of the Application
Applicant’s communication, received February 19, 2026, wherein claims 3-4 and 6 are canceled, claims 5, 7-13, 16-18, and 20-21 are amended, and new claims 22-31 are added, is acknowledged.
Claims 5, 7-31 are pending and examined on the merits herein.
Withdrawn Rejections
Applicant’s amendment, received February 19, 2026, with respect to the rejection of claim 21 under 35 USC § 112(b) as lacking antecedent basis, has been fully considered and found to be persuasive to remove the rejection because claim 21 is amended to depend from claim 5. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 19, 2026, with respect to the rejection of claims 3-5, 11-15, and 17 under 35 USC § 102 as anticipated by Haun, as evidenced by Gemmette and Horlock, has been fully considered and found to be persuasive to remove the rejection because claims 3-4 are canceled and claim 5 is amended to require the specific TCO structure substituted with R1A and -L2-R1B shown in the claim, which Haun does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 19, 2026, with respect to the rejection of claims 3-7, 11-15, and 17 under 35 USC § 102 as anticipated by Qui, as evidenced by Lee and Haun, has been fully considered and found to be persuasive to remove the rejection because claims 3-4 and 6 are canceled and claim 5 is amended to require the specific TCO structure substituted with R1A and -L2-R1B shown in the claim. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 19, 2026, with respect to the rejection of claims 3-5 and 8-21 under 35 USC § 103 as unpatentable over Oneto in view of Robillard, has been fully considered and found to be persuasive to remove the rejection because claim 5 is amended to require the immunomodulatory agent payload is an immune checkpoint inhibitor payload, which the embodiments of Oneto and Robillard cited in the previous rejection did not address. Therefore the rejection is withdrawn.
Applicant’s amendment, received February 19, 2026, with respect to the nonstatutory double patenting rejections of claims 3-5 and 8-21 over the claims of U.S. patents 11,253,600, 12,296,017, and 10,828,373 and U.S. patent applications 18/705,504 and l 7 /624,625 in view of Oneto and/or Robillard, have been fully considered and found to be persuasive to remove the rejection because claim 5 is amended to require the immunomodulatory agent payload is an immune checkpoint inhibitor payload, which the embodiments of Oneto and Robillard cited in the previous rejections did not address. Therefore the rejection is withdrawn.
Response to Arguments
Applicant’s arguments regarding the previous rejections have been fully considered. However, these arguments are moot in view of the new grounds of rejection below.
The following are new and/or modified grounds of rejection in response to Applicant’s amendments received February 19, 2026.
Claim Rejections - 35 USC § 112
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 30-31 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.
Claim 30 depends from claim 7 and requires G, at each occurrence, is linked to one of the one or more lysine residues. Claim 31 depends from claim 7 and requires G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues.
However, claim 7 depend from claim 5, which requires G is linked with L1 and D1, which corresponds to the antibody of claims 30 and 31, is linked to L1. Therefore, because claims 30 and 31 require G linked to one or more lysine residues and G linked to one or more lysine, serine, threonine, or tyrosine residues, claims 30 and 31 fail to include all limitations of the claim upon which they depend, because claim 5 requires G is linked to L1.
This rejection may be overcome by amending claims 30-31 to require G-L1, at each occurrence, is linked to one of the one or more lysine residues or is linked to one or more lysine, serine, threonine, or tyrosine residues.
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
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 5, 7, 12-22, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
Oneto was published October 11, 2018, and thus qualifies as eligible prior art under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
Oneto teaches cyclooctene conjugates of therapeutic agents that have improved aqueous solubility and can the agents upon contact with a tetrazine-containing biomaterial to provide site-selective delivery of agents at the location of the tetrazine-containing biomaterial in a subject (cover page, Abstract, lines 1-3).
Oneto teaches compounds of formula IA, which include a trans-cyclooctene (TCO) moiety linked via a linker to a payload group D (pp. 2-3, [0006]; general structure shown below). Oneto teaches that m in this instance is 1, 2, or 3 (p. 3, line 11).
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Oneto additionally teaches several compounds comprising TCO conjugated to therapeutic agents. As one example, Oneto teaches the compound TCO-Acid-MMAE, which has a carboxylic acid-substituted TCO group conjugated to monomethyl auristatin E (MMAE) (p. 111, Example 11; structure shown below). Regarding the substitution of the TCO group, Oneto teaches that their functionalized payloads have improved aqueous solubility compared with payloads linked to an unsubstituted cyclooctene and therefore are more easily formulated and administered (p. 47, [00163], lines 1-3) (emphasis added). This TCO substitution satisfies the limitations of the TCO group of claim 5 wherein R1A is methyl, L2 is C(O), and R1B is OH, has m as 1 as required by claim 14, satisfies the requirements of the TCO group claims 22, 26, 27, and 28 wherein R1A is methyl and R1B is OH, and is the second structure shown in claim 29.
In addition, this compound has the linker to MMAE as OC(O)L4, wherein L4 is bond, as recited in claim 15, and has the linker as the first structure of G-L1 recited in claim 16.
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Regarding the payloads intended to be conjugated to TCO, Oneto teaches that payloads include therapeutic agents, including anti-cancer agents. Oneto teaches a large number of anti-cancer agents that may be included in their conjugates, including ipilimumab (p. 50, line 18). Ipilimumab is an immune checkpoint inhibitor as required by claim 5, an immune checkpoint inhibitor antibody as required by claim 7, a CTLA4 inhibitor as required by claim 12, and is one of the inhibitors recited in claim 13.
Regarding claims 18 and 21, Oneto teaches their invention provides a compound of formula (I) or (I-A), wherein D is a therapeutic agent, and a therapeutic support composition, the therapeutic support composition comprising a biocompatible support and a tetrazine-containing group for use in the treatment or prevention of a disease or disorder, such as cancer (p. 6, [0014], lines 1-6) (emphasis added). Oneto also teaches the invention provides a compound of formula (I) or (I-A), wherein D is a therapeutic agent, for use in the enhancement or elicitation of an immune response (p. 6, [0015], lines 1-3) (emphasis added). Finally, Oneto teaches their invention includes a method for delivering an effective amount of a payload to a target location in a subject, where the method includes administering to the subject a support composition (p. 7, [020], lines 1-3) (emphasis added).
Oneto teaches specific structures of a therapeutic support composition comprising a tetrazine-containing group. For example, Oneto teaches the therapeutic support compositions may comprise units as shown below (p. 63, [00192]; p. 64, second structure). This therapeutic support composition includes hyaluronic acid as the biocompatible support and satisfies the limitations regarding the therapeutic support composition of claims 18-19 and 21.
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Regarding claim 17, Oneto teaches their conjugates can be provided in any suitable form, (e.g., in the form of a pharmaceutically acceptable formulation), can be formulated for any suitable route of administration (e.g., oral, topical or parenteral administration), and may include pharmaceutically acceptable carriers and excipients (p. 76, [00222], lines 1-7).
Regarding claim 20, Oneto teaches their disclosure include kits with a composition as described, and that a kit may include a support composition or a functionalized payload (p. 134, [00428], lines 1-3).
Oneto does not teach specific conjugate structures that include an immune checkpoint inhibitor payload, as required by claim 5.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to prepare a conjugate comprising a TCO group taught by Oneto linked to a payload, wherein the payload is the CTLA4 inhibitor ipilimumab. One of ordinary skill in the art would have been motivated to prepare a conjugate comprising a TCO group linked to a payload, wherein the payload is the CTLA4 inhibitor ipilimumab, because Oneto teaches conjugates of anti-cancer drugs with TCO that satisfy the limitations of claim 5, and further suggests the anti-cancer drug may be ipilimumab. Moreover, Oneto teaches that their conjugates may be used for the purposes of treating cancer with the tetrazine supports described above, and accordingly, one of ordinary skill in the art would have contemplated practicing the method of treating cancer taught by Oneto with a conjugate of TCO and the CTLA4 inhibitor ipilimumab.
Therefore the invention taken as a whole is prima facie obvious.
Claims 8-11 are rejected under 35 U.S.C. 103 as being unpatentable over Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
Oneto teaches as described in the above rejection under 35 U.S.C. § 103.
Oneto does not teach the immune checkpoint inhibitor antibody payload as a PD-I inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Pennock teaches the role of immune checkpoint inhibitors in cancer treatment (p. 812, Title). Pennock teaches that T-cell responses are partly regulated through a complex balance of inhibitory (“checkpoint”) and activating signals, and that data suggest tumors may exploit inhibitory checkpoint and activating pathways to suppress T-cell activity, limiting antitumor immune responses (p. 814, left column, Targeting T-Cell Checkpoint Pathways section, lines 1-5).
Pennock teaches that key targets of immune checkpoint inhibitory pathways
include CTLA-4, PD-1, and LAG-3. Pennock teaches that ipilimumab, which blocks CTLA-4 to augment antitumor immune responses, was the first checkpoint inhibitor approved for cancer treatment based on its improvements in overall survival (OS) in the treatment of unresectable or metastatic melanoma, and that other agents include the anti-CTLA-4 antibody tremelimumab (melanoma), the PD-1 immune checkpoint inhibitors pembrolizumab (MK-3475) and nivolumab, and the PD-L1 targeted agents MPDL3280A (RG7446) and MEDI-4736 (p. 814, left column, Targeting T-Cell Checkpoint Pathways section, second paragraph, lines 1 to right column, line 7; p. 816, Table 1).
Pennock teaches that pembrolizumab, a PD-1 immune checkpoint inhibitor, produced a median progression-free survival of greater than 7 months in patients with advanced melanoma, some of whom had received prior treatment with ipilimumab (p. 815, right column, PD-1 Immune Checkpoint Pathway section, second paragraph, lines 1-4). Pennock teaches that another PD-1 immune checkpoint inhibitor, nivolumab, achieved sustained OS in patients with advanced solid tumors, including NSCLC, melanoma, and RCC in an early phase clinical trial (p. 816, right column, first full paragraph, lines 1-4).
Pennock further teaches that the anti-PD-L1 antibody MPDL3280A has been evaluated for efficacy in a phase I expansion study in 37 patients with squamous or nonsquamous NSCLC. Pennock teaches that an objective response rate (ORR) of 24% (9 of 37) was observed with a duration of response in the range of >1 to >214 days, and the 24-week progression-free survival was 46% (p. 817, left column, second full paragraph, lines 1-7).
As evidenced by the PubChem entry for Atezolizumab, MPDL3280A is Atezolizumab (pp. 2-3, Synonyms section).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to substitute the immune checkpoint inhibitor antibody ipilimumab in the trans-cyclooctene conjugate obvious over Oneto for a PD-1 or PD-L1 inhibitor antibody. One of ordinary skill in the art would have been motivated to substitute the immune checkpoint inhibitor antibody ipilimumab in the trans-cyclooctene conjugate obvious over Oneto for a PD-1 or PD-L1 inhibitor antibody because Oneto teaches a large number of potential anti-cancer treatments that may be used as payloads in their conjugates, including the immune checkpoint inhibitor antibody ipilimumab, and because Pennock teaches the anti-CTLA-4 antibody ipilimumab, as well as the anti-PD-1 antibodies nivolumab and pembrolizumab and anti-PD-L1 antibody MPDL3280A are promising treatments for treating cancers such as melanoma and lung cancer. Accordingly, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by the prior art for treating cancer, one of ordinary skill in the art would have contemplated substituting ipilimumab for nivolumab, pembrolizumab, or MPDL3280A in the conjugate obvious over Oneto, because a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
In this instance, the rationale “simple substitution of one known element for another to obtain predictable results” would apply. Because Oneto teaches compounds comprising TCO conjugated to anticancer agents, including the immune checkpoint inhibitor ipilimumab, and because Pennock teaches the antibody ipilimumab, as well as the anti-PD-1 antibodies nivolumab and pembrolizumab and anti-PD-L1 antibody MPDL3280A, are effective in preliminary studies for treating cancer, one of ordinary skill in the art would have contemplated substituting nivolumab, pembrolizumab, or MPDL3280A as anticancer agents, because these conjugates may also be effective for treating cancer when practicing the method of treating cancer taught by Oneto.
Therefore the invention taken as a whole is prima facie obvious.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
Robillard was published November 7, 2019, and thus qualifies as eligible prior art under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2).
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Oneto does not teach the conjugate of claim 7, wherein G, at each occurrence, is linked to one of the one or more lysine residues as recited in claim 30, or wherein G, at each occurrence,
is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claim 31.
Robillard teaches compounds that are conjugates between trans-cyclooctene and a compound selected from the group consisting of antibodies, proteins, peptides, and peptoids, which additionally comprise a third linker that extends into solution (cover page, Abstract, lines 1-3). Robillard teaches that the pharmaceutically active compound in their conjugates is selected from a group that includes immunomodulators (p. 60, line 4).
Robillard teaches that the prodrug in their invention is selected so as to target and or address a disease, such as cancer (p. 59, lines 13-14). This is interpreted as teaching that the compounds taught by Robillard are intended to be used for the purposes of treating cancer.
Regarding conjugation of the drug to the TCO group, Robillard teaches the drug and the TCO derivative can be directly linked to each other or bound to each other via a linker (p. 69, 26-28). Robillard further teaches that methods of affecting conjugation to these drugs, for example, through reactive amino acids such as lysine or cysteine in the case of proteins, are known to the skilled person (p. 70, lines 1-2) (emphasis added).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to conjugate the immune checkpoint inhibitor ipilimumab to G-L1 via lysine. One of ordinary skill in the art would have been motivated to conjugate the immune checkpoint inhibitor ipilimumab to G-L1 via lysine because Oneto suggests the antibody ipilimumab as an anti-cancer agent, and because Robillard suggests conjugation of TCO through reactive amino acids such as lysine. Accordingly, when considering the conjugate of claim 5 with the payload as ipilimumab, obvious over Oneto as described above, one of ordinary skill in the art would have contemplated the full scope of conjugation strategies known in the art, including the conjugation strategy taught by Robillard using the reactive amino acid lysine.
Therefore the invention taken as a whole is prima facie obvious.
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 5, 7, 12-22, and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 11, 13, 17, 18, and 19 of U.S. Patent no. 11,253,600 (reference patent, hereinafter ‘600) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
Claim 1 of ‘600 claims a compound of formula (I-A), as shown in the claims, with D as a payload comprising a therapeutic agent or a diagnostic agent. Claims 4-6 and 8 further limit the R1b substituents on the TCO group of formula (I-A).
Claim 11 of ‘600 claims L1 may have the structure:
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.
Claim 13 of ‘600 depends from claim 1 and claims the payload is a therapeutic agent, and claim 14 claims the therapeutic agent is selected from a group that includes anticancer agents.
Claim 17 of ‘600 claims a pharmaceutical composition comprising the compound of claim 11 and a pharmaceutically acceptable carrier.
Claim 18 of ‘600 claims a method of enhancing or eliciting an immune response comprising administering to a subject in need thereof, a therapeutically effective amount of the compound of claim 13, or a pharmaceutically acceptable salt thereof, wherein the therapeutically effective amount enhances or elicits an immune response against a cancer in the subject.
Claim 19 of ‘600 claims a kit comprising the compound of claim 13, or a pharmaceutically acceptable salt thereof, and instructions for use thereof.
The claims of ‘600 do not claim the immune checkpoint inhibitor required by the present claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload comprising the immune checkpoint inhibitor ipilimumab in view of the claims of ‘600 claiming a TCO conjugate comprising an anti-cancer drug payload and Oneto suggesting ipilimumab as an anti-cancer payload that may be conjugated to TCO groups for treating cancer. Accordingly, the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘600 in view of Oneto.
Claims 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 11, 13, 17, 18, and 19 of U.S. Patent no. 11,253,600 (reference patent, hereinafter ‘600) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘600 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘600 do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘600 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘600 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
Claims 30 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8, 11, 13, 17, 18, and 19 of U.S. Patent no. 11,253,600 (reference patent, hereinafter ‘600) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘600 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘600 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claims 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare the conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘600 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
Claims 5, 7, 12-22, and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, and 12 of U.S. Patent no. 12,296,017 (reference patent, hereinafter ‘017) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
The present application and ‘017 are each assigned to Tambo, Inc. and include Jose Manuel Mejia Oneto and Nathan Yee as inventors.
Claim 1 of ‘017 claims a method of treating a cancer or bacterial infection comprising administering to a subject in need a compound of formula (I-A) and a therapeutic support composition as shown in the claim, wherein D is a therapeutic agent selected from an anti-cancer agent and an antibiotic agent.
Claim 2 of ‘017 requires the method is a method of treating is a cancer and the therapeutic agent is an anticancer agent.
Claim 10 of ‘017 requires the biocompatible support is a hyaluronic acid.
Claim 12 of ‘017 depends from claim 1 and claims the compound of formula (I-A) is administered in a pharmaceutical composition further comprising a pharmaceutically acceptable carrier.
The claims of ‘017 do not claim the immune checkpoint inhibitor required by the present claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab in view of the claims of ‘017 claiming a method of treating cancer that requires a TCO conjugate comprising an anti-cancer drug payload, and Oneto suggesting ipilimumab as an anti-cancer payload that may be conjugated to TCO for treating cancer. Accordingly, the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘017 in view of Oneto.
Claims 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, and 12 of U.S. Patent no. 12,296,017 (reference patent, hereinafter ‘017) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘017 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘017 do not claim do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘017 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by the prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘017 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer obvious over the claims of ‘017 in view of Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
Claims 30 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 10, and 12 of U.S. Patent no. 12,296,017 (reference patent, hereinafter ‘017) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘017 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘017 do not claim wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claims 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare the conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘017 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
Claims 5, 7, 12-22, and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 11-13, and 15-16 of U.S. Patent no. 10,828,373 (reference patent, hereinafter ‘373) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
The present application and ‘373 are each assigned to Tambo, Inc. and include Jose Manuel Mejia Oneto as an inventor.
Claim 1 of ‘373 claims a functionalized payload as shown, wherein D is a payload.
Claim 2 of ‘373 claims the alkyl and heteroalkyl of R1 are independently substituted with 0, 1, or 2 substituents, each independently selected from the group consisting of -O, hydroxy and -COOH, which would render obvious the second bioorthogonal TCO group of present claim 16.
Claim 8 of ‘373 claims the functionalized payload of claim 2, or a pharmaceutically acceptable salt thereof, wherein D is selected from a group that includes an anticancer agent.
Claim 11 of ‘373 claims a pharmaceutical formulation comprising the functionalized payload of claim 2, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier.
Claim 12 of ‘373 claims a kit comprising: the functionalized payload of claim 2, or a pharmaceutically acceptable salt thereof; a support composition comprising a tetrazine-containing group as shown.
Claim 13 of ‘373 claims a method for delivering an effective amount of the functionalized payload of claim 2 to a target location in a subject, the method comprising: administering to the subject a support composition comprising a tetrazine-containing group as shown, which satisfy the requirements of present claim 21.
Claim 15 of ‘373 claims a method of treating a cancer, comprising administering to a subject in need thereof a support composition comprising a tetrazine-containing group as shown, which satisfies the requirements of present claim 18, and the functionalized payload of claim 2, and claim 16 requires the support composition is hyaluronic acid.
The claims of ‘373 do not claim the immune checkpoint inhibitors required by the present claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab in view of the claims of ‘373 claiming a functionalized payload D, wherein D is selected from a group that includes an anticancer agent, conjugated to a TCO group, and Oneto suggesting ipilimumab as an anti-cancer payload that may be conjugated to TCO groups for treating cancer. Accordingly, the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘373 in view of Oneto.
Claims 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 11-13, and 15-16 of U.S. Patent no. 10,828,373 (reference patent, hereinafter ‘373) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘373 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘373 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claim 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘373 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘373 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
Claims 30 and 31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 8, 11-13, and 15-16 of U.S. Patent no. 10,828,373 (reference patent, hereinafter ‘373) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘373 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘373 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claim 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare the conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘373 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
Claims 5, 7, 12-22, and 26-29 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,589,162 (reference patent, hereinafter ‘162) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
Claim 1 of ‘162 claims the compound shown in the claim, comprising a substituted TCO conjugated to the anticancer compound monomethyl auristatin E. Claim 2 claims a pharmaceutical composition comprising the compound of claim 1 and a pharmaceutically acceptable carrier.
The claims of ‘162 do not claim the immune checkpoint inhibitor required by the present claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab, because the claims of ‘162 claim a TCO conjugate comprising a monomethyl auristatin E payload, and because Oneto teaches payloads that include monomethyl auristatin E and ipilimumab that may be conjugated to TCO groups for treating cancer. Accordingly, in view of the conjugate claimed by ‘162 and Oneto, one of ordinary skill in the art would have recognized the monomethyl auristatin E payload claimed by ‘162 may be substituted with ipilimumab taught by Oneto, for the purposes of treating cancer using the method taught by Oneto. Therefore the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘162 in view of Oneto.
Claims 8-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,589,162 (reference patent, hereinafter ‘162) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘162 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘162 do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘162 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by the prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘162 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
Claims 30-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 12,589,162 (reference patent, hereinafter ‘162) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘162 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘162 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claim 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare the conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘373 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
Claims 5, 7, and 12-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 54, and 55 of copending U.S. patent application No. 18/705504 (reference application, hereinafter ‘504) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
The present application and ‘504 are each assigned to Tambo, Inc. and include Jose Manuel Mejia Oneto and Nathan Yee as inventors.
The amended claims received February 13, 2025 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘504 claims a targeting moiety of Formula I, Formula II, or Formula V as shown in the claims, which satisfy the therapeutic support composition of present claims 18 and 21.
Claim 54 of ‘504 claims a method of treating cancer or enhancing or eliciting an immune response, the method comprising administering to a subject in need thereof, a therapeutically effective amount of the targeting moiety as shown in claim 1 and a conjugate comprising payload linked to one or more trans-cyclooctene moieties.
Claim 55 of ‘504 further limits the conjugate to those of formula X, wherein D is a payload. In addition, claim 55 claims that the R1b substituent is selected from the group that includes, for example, -NR1c-C1-6alkylene-N(C1-4alkyl)3+, -NR1c-C1-6alkylene-SO3H, -N(R1c)-(CH2CH2O)1-3-CH2CH2N((CH2CH2O)1-3-C1-6alkylene-CO2H)2, and --N(R1c)-CH(CH2O-(CH2CH2O)0-2-C1-6alkylene-CO2H)2. Claim 55 claims that R1c is hydrogen or C1-4alkyl. These linkers are the same R1b groups recited in present claim 23.
The claims of ‘504 do not claim the specific immune checkpoint inhibitors required by the conjugates of the present claims, kits comprising these conjugates, or hyaluronic acid as the biocompatible support of the therapeutic support composition.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab, because the claims of ‘504 claim a method of treating cancer or eliciting an immune response using a TCO conjugate of formula X, and because Oneto suggests ipilimumab as an anti-cancer payload that may be conjugated to TCO groups for treating cancer. Accordingly, the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘504 in view of Oneto.
Regarding claims 23-25, claim 55 of ‘504 claims R1b groups recited in claim 23. In addition, specific R1b groups of claim 24 and the R1c group of claim 25 would have been obvious over these R1b and R1c groups with routine experimentation considering, for example, the number of -CH2CH2O-groups, the ideal alkyl group length, and the ideal R1c group given the parameters provided in claim 55 of ‘504.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 54, and 55 of copending U.S. patent application No. 18/705504 (reference application, hereinafter ‘504) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, and 12-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘504 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘504 do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘504 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘504 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 30 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 54, and 55 of copending U.S. patent application No. 18/705504 (reference application, hereinafter ‘504) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, and 12-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘504 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘504 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claims 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare the conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘504 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 5, 7, 12-22, and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35 and 52-54 of copending U.S. patent application No. 17/624625 (reference application, hereinafter ‘625) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
The present application and ‘625 are each assigned to Tambo, Inc. and include Jose Manuel Mejia Oneto and Nathan Yee as inventors.
The amended claims received July 14, 2025 are cited in this provisional nonstatutory double patenting rejection.
Claim 35 of ‘625 claims a method of treating cancer or enhancing or eliciting an immune
response comprising administering to a subject in need thereof by administering a therapeutically effective amount of a compound of formula (II-A) or (III-A), a therapeutic support composition comprising a support and a tetrazine-containing group as shown, and a therapeutically effective amount one or more immunomodulatory agents. The therapeutic support composition satisfies the requirements of the therapeutic support composition of present claims 18 and 21.
Claim 52 of ‘625 depends from claim 35 and requires the compound has formula (II-A') as shown with D as an anticancer payload and the therapeutic support composition is a substituted hyaluronic acid comprising units of formula (II) as shown. Claim 53 requires groups R1A is CH3 and R1e is -CH2CO2H, which generates the third bioorthogonal moiety structure of claim 16, and Claim 54 requires m is 1.
The claims of ‘625 do not claim the specific immune checkpoint inhibitors required by claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab because the claims of ‘625 claim a method of treating cancer or eliciting an immune response using a TCO conjugate of formula (II-A’) with an anticancer payload, and because Oneto suggests ipilimumab as an anti-cancer payload that may be conjugated to TCO groups for treating cancer. Accordingly, the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘625 in view of Oneto.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35 and 52-54 of copending U.S. patent application No. 17/624625 (reference application, hereinafter ‘625) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘625 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘625 do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘625 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘625 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer obvious over the claims of ‘625 and Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 30 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 35 and 52-54 of copending U.S. patent application No. 17/624625 (reference application, hereinafter ‘625) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘625 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘625 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claims 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare the conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘625 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation via lysine when preparing said conjugate, as suggested by Robillard.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 5, 7, 12-22, and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 47 of copending U.S. patent application No. 19/180813 (reference application, hereinafter ‘813) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
The present application and ‘813 are each assigned to Tambo, Inc. and include Jose Manuel Mejia Oneto and Nathan Yee as inventors.
The amended claims received March 4, 2026 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘813 claims a compound of formula (I-A) as shown, wherein D is a payload selected from the group consisting of auristatin and monomethyl auristatin E.
Claim 47 of ‘813 requires the compound is the compound shown therein, which consists of a substituted TCO group linked with monomethyl auristatin E.
The claims of ‘813 do not claim the immune checkpoint inhibitor required by the present claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab, because the claims of ‘813 claim a TCO conjugate comprising an auristatin or monomethyl auristatin E payload, and because Oneto teaches payloads that include monomethyl auristatin E and ipilimumab that may be conjugated to TCO groups for treating cancer. Accordingly, in view of the conjugates claimed by ‘813 and Oneto, one of ordinary skill in the art would have recognized the auristatin and monomethyl auristatin E payloads claimed by ‘813 may be substituted with ipilimumab taught by Oneto. Therefore the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘813 in view of Oneto.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented. However, a notice of allowance has been mailed in this application, and upon issue of the corresponding patent, this provisional nonstatutory double patenting rejection will become a nonstatutory double patenting rejection.
Claims 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 47 of copending U.S. patent application No. 19/180813 (reference application, hereinafter ‘813) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘813 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘813 do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘813 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by the prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘625 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented. However, a notice of allowance has been mailed in this application, and upon issue of the corresponding patent, this provisional nonstatutory double patenting rejection will become a nonstatutory double patenting rejection.
Claims 30 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 47 of copending U.S. patent application No. 19/180813 (reference application, hereinafter ‘813) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘813 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘813 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claims 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘813 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented. However, a notice of allowance has been mailed in this application, and upon issue of the corresponding patent, this provisional nonstatutory double patenting rejection will become a nonstatutory double patenting rejection.
Claims 5, 7, 12-22, and 26-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 49 of copending U.S. patent application No. 19/540228 (reference application, hereinafter ‘228) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action).
The present application and ‘228 are each assigned to Tambo, Inc. and include Jose Manuel Mejia Oneto and Nathan Yee as inventors.
The amended claims received February 13, 2026 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘228 claims a compound of formula (I-A) as shown, wherein D is a payload selected from the group consisting of vancomycin and daptomycin.
Claim 49 of ‘813 requires the compound is the compound shown therein, which consists of a substituted TCO group linked with daptomycin.
The claims of ‘228 do not claim the immune checkpoint inhibitor required by the present claims 5, 7, 12-22, and 26-29.
Oneto teaches as described in the above rejection under 35 U.S.C. § 103. In addition, Oneto teaches that representative payloads include therapeutic agents for treating cancer and antibiotics, such as vancomycin and daptomycin (p. 27, [00133], lines 1-6).
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate of the present claims with an anticancer drug payload of the immune checkpoint inhibitor ipilimumab in view of the claims of ‘228 claiming a TCO conjugate comprising payloads of vancomycin and daptomycin and Oneto teaching TCO conjugates with payloads that include antibiotics and anti-cancer agents, further suggesting ipilimumab as one anti-cancer payload. Accordingly, in view of the conjugates claimed by ‘228, one of ordinary skill in the art would have recognized the antibiotic payloads claimed by ‘228 may be substituted for the anticancer agents taught by Oneto, such as ipilimumab, and used in the method of treating cancer taught by Oneto. Accordingly, the methods, composition, and kit recited in the present claims are also obvious over the claims of ‘228 in view of Oneto.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 8-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 49 of copending U.S. patent application No. 19/540228 (reference application, hereinafter ‘228) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Pennock (Pennock, G. K. et al. The Oncologist 2015, vol. 20, pp. 812-822; cited in PTO-892), as evidenced by PubChem (PubChem entry for Atezolizumab; cited in PTO-892).
The claims of ‘228 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘228 do not claim the immune checkpoint inhibitor antibody payload as a PD-1 inhibitor payload or a PD-L1 inhibitor payload, as required by claims 8-11.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Pennock teaches as described in the above rejections under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to substitute the immune checkpoint inhibitor ipilimumab in the conjugate obvious over the claims of ‘228 in view of Oneto for the PD-1 inhibitor antibodies nivolumab and pembrolizumab or PD-L1 inhibitor antibody MPDL3280A, because each of ipilimumab, nivolumab, pembrolizumab, and MPDL3280A are recognized by the prior art for treating cancer. Therefore, one of ordinary skill in the art would have contemplated substitution of ipilimumab in the conjugate obvious over the claims of ‘228 in view of Oneto for nivolumab, pembrolizumab, or MPDL3280A, because such a conjugate comprising nivolumab, pembrolizumab, or MPDL3280A may also be effective when practicing the method of treating cancer taught by Oneto.
As evidenced by the PubChem entry for atezolizumab, MPDL3280A is the same antibody as atezolizumab (pp. 2-3, Synonyms section).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Claims 30 and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 49 of copending U.S. patent application No. 19/540228 (reference application, hereinafter ‘228) in view of Oneto (Publication no. WO 2018187740 A1; cited in previous office action) as applied to claims 5, 7, 12-22, and 26-29 above, and further in view of Robillard (Publication no. WO 2019212357 A1; cited in previous office action).
The claims of ‘228 claim as described in the above nonstatutory double patenting rejection.
The claims of ‘228 do not claim the wherein G, at each occurrence, is linked to one of the one or more lysine residues or wherein G, at each occurrence, is independently linked to one or more lysine, serine, threonine, or tyrosine residues, as recited in claims 30 and 31.
Oneto teaches as described in the above rejections under 35 U.S.C. § 103.
Robillard teaches as described in the above rejection under 35 U.S.C. § 103.
It would therefore have been prima facie obvious to one of ordinary skill in the art to prepare a conjugate comprising the immune checkpoint inhibitor ipilimumab, obvious over the claims of ‘228 in view of Oneto, by conjugating ipilimumab via a reactive lysine residue, because Robillard suggests preparation of conjugates comprising trans-cyclooctene through reactive amino acids such as lysine. Accordingly, one of ordinary skill in the art would have contemplated conjugation of ipilimumab to trans-cyclooctene with the full scope of conjugation strategies known in the art, including conjugation via lysine, as suggested by Robillard.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Conclusion
No claims are allowed.
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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693
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