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 January 4, 2022, is a national stage application of
PCT/US2020/040891, filed July 6, 2020, which claims the benefit of U.S. provisional applications 62/871051, filed July 5, 2019, 62/971196, filed February 6, 2020, and 62/981401, filed February 25, 2020.
Claims 35-37, 47-49, 53, 55 and 58 are drawn to a method of treating cancer or enhancing or eliciting an immune response, comprising administering a therapeutically effective amount of a compound of formula (II-A’), a substituted hyaluronic acid comprising units of formula (II), and a therapeutically effective amount of one or more STING agonists.
The subject matter of claims 35-37, 47-49, 53, 55 and 58 is not supported by provisional application 62/871051, filed July 5, 2019. 62/871051 teaches payload D may be TLR agonists and STING agonists, which are each immunomodulatory agents (p. 22, [0085] and [0086]), but does not teach a method requiring administration of a therapeutically effective amount of a compound of formula (II-A’), a therapeutic support composition, and a therapeutically effective amount of one or more STING agonists agents. Provisional application 62/971196, filed February 6, 2020, does support the method of claim 35 (for example, see claims 1, 13, and 19 of 62/971196) and its dependent claims. Therefore, claims 35-37, 47-49, 53, 55 and 58 are examined with the effective filing date of February 6, 2020.
Status of the Application
Applicant’s communication, received April 21, 2026, wherein claims 35, 53, 55, and 58 are amended and claims 38, 43-46, 50-52, 54, and 56-57 are canceled, is acknowledged.
Claims 35-37, 47-49, 53, 55, and 58 are pending and examined on the merits herein.
Withdrawn Objections
Applicant’s amendment, received April 21, 2026, with respect to the objection to claim 35 for a minor informality, has been fully considered and found to be persuasive to remove the objection because claim 35 is amended to remove the informality. Therefore the objection is withdrawn.
Withdrawn Rejections
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claims 35-37 and 47-50 under 35 USC § 103 as unpatentable over Oneto in view of Robillard and Jing, has been fully considered and found to be persuasive to remove the rejection because claim 35 is amended to require R1A as C1-4 alkyl and R1B as OH, -N(R1C)CHR1eCO2H, or -N(R1C)-C1-6alkylene-CO2H, which are not taught by the combination of Oneto, Robillard, and Jing. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claims 35-37 and 47-50 under 35 USC § 103 as unpatentable over Oneto in view of Robillard and Pratesi, has been fully considered and found to be persuasive to remove the rejection because claim 35 is amended to require R1A as C1-4 alkyl and R1B as OH, -N(R1C)CHR1eCO2H, or-N(R1C)-C1-6alkylene-CO2H and to require the immunomodulatory agent is a STING agonist, which are not taught by the combination of Oneto, Robillard, and Pratesi. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claims 44-46 under 35 USC § 103 as unpatentable over Oneto in view of Robillard, Jing, and Khan, has been fully considered and found to be persuasive to remove the rejection because claims 44-46 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claim 43 under 35 USC § 103 as unpatentable over Oneto in view of Robillard, Jing, Khan, and Geiger, has been fully considered and found to be persuasive to remove the rejection because claim 43 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claims 35-38, 47-49, and 52-58 under 35 USC § 103 as unpatentable over Yee in view of Hershberg, has been fully considered and found to be persuasive to remove the rejection because claim 35 is amended to require the immunomodulatory agent is a STING agonist, which is not taught by the combination of Yee and Hershberg. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claims 44-46 under 35 USC § 103 as unpatentable over Yee in view of Khan and Hershberg, has been fully considered and found to be persuasive to remove the rejection because claims 44-46 are canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the rejection of claim 43 under 35 USC § 103 as unpatentable over Yee in view of Hershberg, Khan, and Geiger, has been fully considered and found to be persuasive to remove the rejection because claim 43 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received April 21, 2026, with respect to the nonstatutory double patenting rejections of the previous claims as unpatentable over the claims of U.S. patent nos. 10,828,373, 11,253,600, and 12,296,017 and U.S. patent application 18/705,504, together with the secondary references in the previous office action, have been fully considered and found to be persuasive to remove the rejections because claim 35 is amended to require the therapeutic agent is doxorubicin, specific trans-cyclooctene substituents, and administration with a STING agonist, the combination of which are not taught by the embodiments cited in the previous nonstatutory double patenting rejections. Therefore the rejections are withdrawn.
The following are new and/or modified grounds of rejection, necessitated by Applicant’s amendment received April 21, 2026. Applicant’s arguments received April 21, 2026 are moot in view of the new grounds of rejection below.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35
U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 35, 53, 55, and 58 are rejected under 35 U.S.C. 103 as being unpatentable over Yee (Publication no. WO 2018187740 A1; cited in IDS received July 28, 2022) in view of Iyer (Publication no. WO 2019161171 A1; cited in PTO-892).
Yee was published October 11, 2018 and thus qualifies as eligible prior art under 35 U.S.C. 102(a)(1) given the effective filing dates of the claims described in the above priority section.
Iyer was published August 22, 2019, and thus qualifies as eligible prior art under 35 U.S.C. 102(a)(1) given the effective filing dates of the claims described in the above priority section.
Claim 35 claims a method of treating cancer or enhancing or eliciting an immune response comprising administering to a subject in need thereof: a) a therapeutically effective amount of a compound of formula (II-A’), b) a substituted hyaluronic acid comprising units of formula (II) as shown, and c) a therapeutically effective amount one or more immunomodulatory agents, wherein the one or more immunomodulatory agents is a STING agonist.
Claims 53, and 55 further limit the compound of formula (II-A’), and claim 58 requires the tetrazine-containing group is incorporated into the hyaluronic acid from 10% to 50%.
Yee teaches cyclooctene conjugates of therapeutic agents that have improved aqueous solubility and can release 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).
Yee teaches several conjugates comprising cyclooctene conjugated to therapeutic agents. As one example, Yee teaches an embodiment wherein trans-cyclooctene is modified with glycine and conjugated to the therapeutic agent doxorubicin (p. 112, synthetic scheme for Example 12; synthesis described in [00377]; structure shown below). This compound also satisfies all limitations of the compound of formula (II’) recited in the present claim 35, wherein R1A is C1 alkyl, R1B is -N(R1C)-C1-CO2H, and the other variable groups are as required by claims 35 and claim 55.
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Furthermore, relating to the general structure of formula (I-A) recited in claim 1 of Yee (p. 136, claim 1), Yee claims variable group L2 is -C(O)- (p. 137, claim 5) and R1b may be -N(H)CHR1eCO2H, with R1e as -CH2CO2H (p. 138, claim 6), which are substituents at the same position of glycine in TCO-Gly-Dox. These definitions of L2 and R1b claimed by Yee would provide an aspartic acid substituent on the trans-cyclooctene group in place of the glycine group of TCO-Gly-Dox above, thus satisfying the requirements of claim 53.
Moreover, Yee teaches an embodiment wherein trans-cyclooctene is modified with aspartic acid and conjugated to the therapeutic agent daptomycin (p. 113, Synthetic scheme at top of page; synthesis described in [00378]; structure shown below). This structure has the carboxylic acid substituent of trans-cyclooctene condensed with aspartic acid.
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In addition, Yee teaches and claims a method of treating a condition or disorder comprising administering a therapeutically effective amount of the compound of any of claims 14-16 or the pharmaceutical composition of claim 19 and a therapeutic support composition, the therapeutic support composition comprising a biocompatible support and a tetrazine-containing group of formula as shown in the claim (p. 146, claim 25), which has the same limitations of the tetrazine-containing group recited in the present claim 35. TCO-Acid-MMAE and TCO-Gly-Dox have payloads as pharmaceutical agents, as required by claim 14 of Yee (p. 142), and thus falls within the scope of the method claimed by Yee.
Yee further teaches and claims the therapeutic support compositions shown in claims 23 and 24 wherein G2 is as shown (p. 144, claims 23 and 24). In addition, Yee teaches the therapeutic support compositions may comprise units as shown below (p. 63, [00192]; p. 64, second structure), which satisfy the requirements of the substituted hyaluronic acid comprising units of formula (II).
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Moreover, Yee teaches the tetrazine-containing group can be incorporated into the hyaluronic acid from about 0.1 % to about 80% as measured by the percent of carboxylic acids being linked or conjugated to the tetrazine-containing group, such as about 1% to about 75%, about 5% to about 75%, about 10% to about 50%, or about 40% to about 75% (p. 64, [00195], line 2 to p. 65, line 3).
In addition to their method described above, Yee teaches their 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, [0014], lines 1-3), and suggests these compounds may be used for treating diseases such as inflammation and autoimmune disorders (p. 6, [0016], lines 3-5). Therefore, one of ordinary skill in the art would have recognized the method of Yee may also be used in the enhancement or elicitation of an immune response.
Finally, Yee teaches that the disclosed methods provide the ability to place particles as
disclosed herein at the time of the biopsy, and when the results return, the practitioner can deliver
through to the biopsy site chemokines (agents that attract cancerous cells and/or immune cells) and adjuvants to enhance the immune system with fewer side effects as well as chemotherapeutics agents combined with immunotherapy agents (p. 82, [00244], line 1 to p. 83, line 2) (emphasis added).
Yee does not teach a method of enhancing or eliciting an immune response that includes administration of one or more STING agonists, as required by claim 35.
Iyer teaches and claims a method of inducing an immune response in a subject, comprising administering to the subject a therapeutically effective amount of a compound of a nanoparticle or composition claimed (p. 377, claim 148). Iyer teaches that their invention includes nanoparticles comprising STING agonists which activate in a host the innate immune defense system and induce expression of pattern recognition receptors (p. 1, Field of Disclosure section, lines 1-3). The induction of an immune response is interpreted as equivalent to the enhancing or eliciting an immune response, as recited in claim 35. Therefore, in view of Iyer, one of ordinary skill in the art would have contemplated administering a STING agonist for the purposes of inducing an immune response in a subject.
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 administer a STING agonist taught by Iyer in combination with the TCO-modified doxorubicin and the therapeutic support composition taught by Yee for the purposes of eliciting an immune response. One of ordinary skill in the art would have been motivated to administer a STING agonist taught by Iyer in combination with the TCO-modified doxorubicin and the therapeutic support composition taught by Yee for the purposes of eliciting an immune response because each of Yee and Iyer teach their methods for the purposes of eliciting an immune response, and thus administration of the STING agonist of Iyer with the compound of formula (II-A’) and hyaluronic acid of formula (II) of Yee is prima facie obvious, because this combination may be effective for eliciting an immune response than either the method of Iyer or method of Yee practiced alone.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because the methods of each of Yee and Iyer are drawn to the same purpose, elicitation of an immune response, the administration of the STING agonist taught by Iyer with the method of Yee for the same purpose as each are taught individually is prima facie obvious.
Regarding the requirement of claim 58 wherein the tetrazine-containing group is incorporated into the hyaluronic acid from 10% to 50%, because Yee teaches the tetrazine-containing group can be incorporated into the hyaluronic acid from about 0.1 % to about 80% as measured by the percent of carboxylic acids being linked or conjugated to the tetrazine-containing group, such as about 1% to about 75%, about 5% to about 75%, about 10% to about 50%, or about 40% to about 75% as measured by the % of carboxylic acids being linked or conjugated to the tetrazine-containing group, one of ordinary skill in the art would have contemplated different levels of incorporation of tetrazine into hyaluronic acid, including levels between 10 and 50%, as recited by Yee, and would have adjusted the level of tetrazine incorporation to optimize release of the drug from the TCO-conjugates when treating cancer.
Therefore the invention taken as a whole is prima facie obvious.
As discussed below, Applicant’s Declaration is persuasive evidence of nonobviousness to overcome rejections over claims drawn to a method of treating cancer. However, because Yee and Iyer render obvious the method of enhancing or eliciting an immune response of claim 35, and Applicant’s Declaration only includes evidence of nonobviousness for treating cancer, the unexpected results are not commensurate with the current scope of claim 35, absent evidence that the claimed method also provides superior enhancement of an immune response.
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 35, 53, 55, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 13, 15, and 16 of U.S. Patent No. 11,253,600 (reference patent, hereinafter ‘600) in view of Yee (Publication no. WO 2018187740 A1; cited in IDS received July 28, 2022) and Iyer (Publication no. WO 2019161171 A1; cited in PTO-892).
The present application and ‘600 are each assigned to Tambo Inc.
Claim 1 of ‘600 claims a compound of formula (I-A) as shown. Claim 4 requires R1a as CH3, claim 5 requires L-2 as -C(O)- and claim 6 claims R1b is selected from a group that includes N(H)CH2CO2H and N(H)CHR1cCO2H, wherein R1C is CH2CO2H. Together, these substituents of R1a and R1b render obvious the substituents the compound of formula (II-A’) in present claims 35, 53, and 55.
Claim 13 claims the payload is a therapeutic agent, claim 15 claims the therapeutic agent is a payload selected from the group recited in the claims, which includes doxorubicin and gemcitabine, and claim 16 claims the compound is as shown, which has doxorubicin conjugated to trans-cyclooctene modified with methyl and glycine groups. This compound satisfies the limitations of the compound of formula (II-A’) recited in claims 35 and 53.
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The claims of ‘600 do not claim administering also administering the required therapeutic support composition and an immunomodulatory agent, as required by the present claims.
Yee and Iyer teach 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 administer a), b) and c) of claim 35 for the purposes of enhancing or eliciting an immune response because ‘600 claims the compound TCO-Gly-Dox (see claim 16), Yee teaches the compound TCO-Gly-Dox and teaches a method of enhancing or eliciting an immune response using compounds of their invention, and Iyer teaches administration of a STING agonist for the purposes of inducing an immune response.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because the methods of each of Yee and Iyer are drawn to the same purpose, elicitation of an immune response, and because ‘600 claims a compound taught by Yee that may be used for practicing the above method, the administration of a STING agonist taught by Iyer with TCO-Gly-Dox and the compound of Formula (II) for eliciting an immune response is prima facie obvious, because administration of these therapies together may be more effective for eliciting an immune response than when administered alone.
Claims 35, 53, 55, and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 10, 13, and 14 of U.S. Patent No. 12,296,017 (reference patent, hereinafter ‘017) in view of Yee (Publication no. WO 2018187740 A1; cited in IDS received July 28, 2022) and Iyer (Publication no. WO 2019161171 A1; cited in PTO-892).
The present application and ‘017 are each assigned to Tambo Inc.
Claim 1 of ‘017 claims a method of treating a cancer or bacterial infection comprising administering to a subject in need thereof, a therapeutically effective amount of a compound of formula (I-A) as shown and a therapeutic support composition with formula as shown. Claim 2 claims the method is a method of treating is a cancer and the therapeutic agent is an anticancer agent, claim 3 claims the cancer is a melanoma, renal cancer, prostate cancer, ovarian cancer, breast cancer, glioma, lung cancer, soft tissue carcinoma, soft tissue sarcoma, osteosarcoma, or pancreatic cancer, claim 4 claims the cancer is a solid tumor, claim 5 claims the cancer is a soft tissue sarcoma, claim 10 claims the biocompatible support comprises substituted hyaluronic acid units of formula (II) as shown, claim 13 claims the anticancer agent is doxorubicin, and claim 14 claims the compound of formula (I-A) is the conjugate below, which has doxorubicin conjugated to trans-cyclooctene modified with methyl and glycine groups. This TCO moiety satisfies the requirements of the present claim of formula (II-A’) of claims 35, 53, and 55.
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The claims of ‘017 do not claim a method of enhancing or eliciting an immune response by administering a), b), and c) as required by the present claims.
Yee and Iyer teach 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 administer a), b) and c) of claim 35 for the purposes of enhancing or eliciting an immune response because ‘017 claims the compound TCO-Gly-Dox (see claim 16) for use in a method of treating a cancer or bacterial infection, because Yee also teaches TCO-Gly-Dox and teaches a method of enhancing or eliciting an immune response using compounds of their invention, and because Iyer teaches administration of a STING agonist for the purposes of eliciting an immune response.
In this instance, the rationale “combining prior art elements according to known methods to yield predictable results” would apply. Because the methods of each of Yee and Iyer are drawn to the same purpose, induction or elicitation of an immune response, and because ‘017 claims use of a compound taught by Yee for practicing the above method, the administration of a STING agonist taught by Iyer with TCO-Gly-Dox and the compound of Formula (II) for eliciting an immune response is prima facie obvious, because administration of these therapies together may be more effective for eliciting an immune response than when administered alone.
Allowable Subject Matter
Claims 36, 37, and 47-49 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 36 depends from claim 35 and requires the method is the method of enhancing or eliciting an immune response wherein the administration of a), b ), and c) enhances or elicits an immune response against a cancer in the subject.
Claim 37 depends from claim 35 and requires the method is the method of treating cancer. Claims 47-49 further limit the method of treating cancer.
The closet prior art to these claims is considered the combination of Yee and Iyer, as described above in the above rejection under 35 U.S.C. 103. In addition, Yee teaches their method may be used for treating cancer (pp. 145-146, claims 26-30), and Iyer teaches and claims a method of treating cancer in a subject comprising administering to the subject a therapeutically effecting amount of a nanoparticle or composition of their invention (p. 376, claim 141), which include STING agonists. Accordingly, the Office maintains that it would have been obvious to combine the method of Yee with the teachings of Iyer and administer a STING agonist when practicing the method of Yee for the purposes of treating cancer. However, Applicant has submitted persuasive evidence of nonobviousness related to the claimed method of treating cancer.
Applicant’s declaration under 37 C.F.R. § 1.132 provides evidence of superior results when practicing the method of claim 35 for the purposes of treating cancer. Applicant’s declaration provides data regarding a comparative study of anti-tumor effects in mice of a STING agonist (ADU-S100), SQ3370 treatment (which administers a) and b) of claim 35), and combined SQ3370 treatment+ STING agonist treatment (which administers a), b) and c) of claim 35).
In this study, SQ3370 treatment consisted of local tumor administration of SQL 70 biopolymer and systemic administration of TCO-Gly-Dox (Applicant’s declaration, p. 2). This study shows the mean tumor volume for the SQ3370 + STING agonist group shows significantly smaller mean tumor volume at days 13 and 20 compared with either SQ3370 or the ADU-S100 alone (Applicant’s declaration, pp. 4 and 5). The results of this study demonstrate that the combination SQ3370 + STING agonist treatment shows an unexpectedly superior antitumor effect compared to SQ3370 treatment alone.
The Office has not identified eligible prior art that would teach or suggest synergistic activity between doxorubicin and a STING agonists for treating cancer. Zhou (Zhou, M.; et al. Advanced Healthcare Materials 2020, vol. 9, 2000064; cited in PTO-892) teaches STING-activating nanoparticles that include doxorubicin for the purposes of anti-tumor immunotherapy, further showing that the addition of doxorubicin improves the anticancer activity of the STING-activating nanoparticle (p. 6, Figure 4). However, Zhou was published on June 2, 2020, and thus is not eligible as prior art.
Regarding the unexpected results and the scope of claim 35, Applicant’s declaration provides that SQ3370 + STING agonist shows unexpectedly superior antitumor effect in mice with tumors derived from the MC38 cell line, which are derived from murine colon adenocarcinoma cells. However, prior art provides that doxorubicin and STING agonists may be administered for the purposes of treating a large scope of cancers. Iyer teaches and claims a method of treating cancer in a subject comprising administering to the subject a therapeutically effecting amount of a nanoparticle or composition of their invention (p. 376, Claim 141), which as described above, is drawn to compounds that act as STING agonists. Iyer further claims their method as applied to a broad scope of more specific cancers (p. 376, claims 142 and 143). Rivankar (Rivankar, S.; Journal of Cancer Research and Therapeutics 2014, vol. 10, pp. 853-858; cited in PTO-892) teaches the therapeutic uses of doxorubicin include treatment of leukemia, lymphomas, breast cancer, and lung cancer, among many other types of cancer (p. 854, Table 1). Therefore, because each of doxorubicin and STING agonists are recognized in the prior art for treating a broad scope of cancers, one of ordinary skill in the art would have had a reasonable expectation that the claimed combination would show activity against a broad scope of cancers.
Regarding the method of claim 36, wherein the method is the method of enhancing or eliciting an immune response wherein the administration of a), b ), and c) enhances or elicits an immune response against a cancer in the subject, because the prior art provides an expectation that a STING agonist will enhance an immune response against cancer, one of ordinary skill in the art would reasonably expect that such a mechanism is involved in achieving the superior results provided in Applicant’s Declaration. Therefore, claim 36 would also be allowable if incorporated into an independent claim.
Conclusion
Claims 35, 53, 55, and 58 are rejected.
Claims 36, 37, and 47-49 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.M.B./ Examiner, Art Unit 1693
/ANDREA OLSON/ Primary Examiner, Art Unit 1693
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