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 .
Current Status
This action is responsive to the amended claims of 08/21/2026. Claims 24-43 are pending. Claims 29-31 are withdrawn. Claims 24-28 and 32-43 have been examined on the merits.
Election/Restrictions
Applicant’s election without traverse of the species: compound 1 (12-tigloyl-13-(2-methylbutanoyl)-6,7-epoxy-4,5,9,12,13,20-hexahydroxy-1-tigliaen-3-one), cisplatin, and squamous cell carcinoma in the reply filed on 08/21/2026 is acknowledged.
A search for the elected species retrieved art (see SEARCH 6 of the attached search notes). Thus, per Markush search practice, the search will not be extended unnecessarily to additional species in this Office Action.
The elected species read on claims 24-28 and 32-43.
Claims 29-31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/21/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
The effective filing date is 02/17/2022.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 05/02/2025 and 08/15/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Please amend the title to reflect the combination therapy of epoxytigliane compounds and secondary therapeutics.
Claim Objections
Claims 24-28 and 32-43 are objected to because of the following informalities. Appropriate correction is required.
Claim 24 recites under R9 line two:
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. Please replace the annotated semicolon with a comma so as to unify the punctuation used. Dependent claims 25-28 and 32-43 are similarly objected to since they do not rectify the underlying issue.
Claim 32 recites under ii) R2 and R3 line three:
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. Please replace the annotated semicolon with a comma so as to unify the punctuation used. Dependent claims 33-34 are similarly objected to since they do not rectify the underlying issue.
Claim 41 recites “squamous cell cancer”. While squamous cell cancer and squamous cell carcinoma (as recited by parent claim 39) are understood to be synonymous, it is preferred if the word choice between claims is consistent. Please replace “squamous cell cancer” in claim 41 with “squamous cell carcinoma”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 35 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 35 recites, in the final line, “wherein R6, R7 and R9 are as defined in claim 1.” Claim 1 is canceled. Therefore, the scope of moieties which R6, R7, and R9 are chosen from is undefined. Thus, the metes and bounds of the claim are undefined rendering the claim indefinite.
To overcome: please replace the recitation of “claim 1” with “claim 24”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 35 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 35 recites “The method according to claim 24”; however, it later recites “wherein R6, R7 and R9 are as defined in claim 1.” Claim 1 is canceled – a claim cannot depend on a canceled claim. Further, since the scope of R6, R7 and R9 is defined by claim 1, claim 35 cannot properly further limit the claim 24 from which it depends. Thus, claim 35 is of improper dependent form.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 24-28 and 32-43 are rejected under 35 U.S.C. 103 as being unpatentable over BARNETT (Barnett, C.M.E., et al., Investigational New Drugs, pub. 2018, 37, 1-8; provided IDS of 05/02/2025) in view of CASTRO (Castro, D.J., et al., Journal of the Sciences and Specialties of the Head & Neck, 2003, 25(9), 717-731), and in view of REDDELL (WO 2018/170559; provided IDS of 05/02/2025).
The instant claims are drawn to a method of treating tumors by administering Formula (I) and a second therapeutic agent (claim 24, 32-36, & 42) separately and simultaneously (claim 37). Formula (I) is administered via intratumoral injection (claims 25-26). The second agent is cisplatin (claims 27-28 & 43). The tumor is a mucosal, subcutaneous HNSCC tumor (instant claims 38-41).
Determining the Scope and Contents of the Prior Art:
BARNETT teaches tigilanol tiglate, also known as 12-tigloyl-13-(2-methylbutanoyl)-6,7-epoxy-4,5,9,12,13,20-hexahydroxy-1-tigliaen-3-one, (i.e., instant compound 1) (Pg. 1 Right col. last ¶), reproduced here:
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. Tigilanol tiglate reads on instant Formula (I) wherein R1 is Me, R2 is -OR9, R3 is -OR9, R4-5 are each Me, R6 is H, R7 is OH, R8 is Me, R9 is -C(O)C4alkenyl for R2 and is -C(O)C4alkyl for R3. Administration of tigilanol tiglate treated head and neck squamous cell carcinoma (HNSCC) in mice (Pg. 4 Fig. 1-2). The tigilanol tiglate was administered by intratumoral injection (Pg. 2 Right col. last ¶); this was confirmed to be the most efficacious treatment for the HNSCC mouse model (Pg. 1 Abstract). The HNSCC tumors were subcutaneous xenografts of a tongue (i.e, mucosal) SCC cell line (Pg. 1 Abstract).
CASTRO teaches intratumoral injections of aqueous cisplatin solutions have marginal success – to overcome this, the study developed an improved cisplatin/epinephrine injectable gel (Pg. 718 Right-Left col. ¶2-3). Human patients with HNSCC tumors in the oral cavity and other mucosal regions (Pg. 721 Results & Table 1) were treated with the cisplatin/epinephrine injectable gel by intratumoral injection (Pg. 719-720 Drug Administration bridge ¶). The tumors were subcutaneous (Pg. 724 Table 4). 76% of patients had an overall clinical benefit from the treatment (Pg. 725 Table 5). The improved intratumoral injection has benefits of rapid onset, durability of response, and rarity of systemic toxicities (Pg. 728 Right col. ¶2).
REDDELL teaches compounds of instant Formula (I), specifically the exact chemical names of compounds 1-10 recited in instant claim 36 (Pg. 14 Line 7-24 & Pg. 15 Line 1-3). The compounds 1-10 activate PKC isoforms, which is important to regulating cellular proliferation (Pg. 25-27 Example 1). REDDELL teaches a method of treating a tumor comprising administering epoxytigliane compounds (including compounds 1-10) and an immune checkpoint inhibitor (ICI) (Pg. 45 claim 1 & Pg. 48 claim 17). The epoxytigliane compound and ICI are administered simultaneously and separately (Pg. 49 claim 23, Pg. 8 Lines 14-20).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
While BARNETT teaches intratumoral injection of instant compound 1 (instant claims 24-26, 32-36, & 42) treats a mucosal, subcutaneous HNSCC tumor (instant claims 38-41), BARNETT does not teach combination treatment with cisplatin.
While CASTRO teaches treatment of mucosal, subcutaneous HNSCC tumor (instant claims 38-41) with cisplatin (instant claims 24, 27-28, & 43), CASTRO does not teach combination treatment with a compound of Formula (I).
While REDDELL teaches combination treatment of Formula (I) and a secondary therapeutic simultaneously and separately (instant claim 37), REDDELL does not teach the secondary therapeutic is cisplatin.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of epoxytigliane combination therapies useful for treatment of cancers such as squamous cell cancer and possesses the technical knowledge necessary to make adjustments to the drugs administered to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment of squamous cell cancer and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references BARNETT, in view of CASTRO, and in view of REDDELL.
The artisan would be motivated to combine an intratumoral injection of tigilanol tiglate (i.e., instant compound 1) with an intratumoral injection of cisplatin to treat head and neck squamous cell carcinoma (HNSCC) since BARNETT teaches treatment of mucosal, subcutaneous HNSCC tumor with intratumoral tigilanol tiglate (Pg. 2 Right col. last ¶) and CASTRO teaches treatment of mucosal, subcutaneous HNSCC tumor with intratumoral cisplatin (Pg. 719-720 bridge ¶).
The artisan would have a reasonable expectation of success that by combining tigilanol tiglate (i.e., instant compound 1) with cisplatin, one would have achieved a composition useful for treating HNSCC since both are taught by the prior art as suitable for the treatment of such. As set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art.
Moreover, REDDELL teaches treatment of tumors by combination therapy of compounds of instant Formula (I) and a secondary therapeutic agent (Pg. 45 claim 1 & Pg. 48 claim 17). Thus, the artisan would have an expectation of success in combining compounds of Formula (I) with another therapeutic agent. Further, the artisan would have motivation to substitute one functional equivalence (ICI – an anticancer drug) for another (cisplatin – an anticancer drug) with an expectation of success, since the prior art establishes that both function in a similar manner (i.e., treat tumors), thus resulting in the practice of the instant claims, with a reasonable expectation of success.
The artisan would expect success when administering the compound of Formula (I) (i.e., tigilanol tiglate) and the cisplatin simultaneously since REDELL teaches the combination therapies of Formula (I) are administered simultaneously and separately (Pg. 49 claim 23, Pg. 8 Lines 14-20). Further, the artisan would be motivated to administer the two as separate compositions since the intratumoral compositions of tigilanol tiglate and cisplatin have each, separately, been optimized in BARNETT (Pg. 1 Abstract) and CASTRO (Pg. 718 Right-Left col. ¶2-3) for such administration. Further, the artisan would have motivation to utilize intratumoral injection to leverage the benefits of rapid onset and reduced systemic toxicity, as recognized by CASTRO (Pg. 728 Right col. ¶2).
Since BARNETT (Pg. 1 Right col. last ¶) and REDDELL (Pg. 14 Line 7-24 & Pg. 15 Line 1-3) teach compound 1 and compounds 1-10, respectively, of the instant claims 36 and 43, and each compound is found to have anticancer activity (BARNETT (Pg. 4 Fig. 1-2)) via PKC activation specifically (REDDELL (Pg. 25-27 Example 1)), the artisan would be motivated, with an expectation of success, to use any one of the instant compounds of Formula (I) (1-10) within the combination treatment.
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 24-28 and 32-43 are rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 9,289,410 in view of BARNETT (Barnett, C.M.E., et al., Investigational New Drugs, pub. 2018, 37, 1-8; provided IDS of 05/02/2025), in view of CASTRO (Castro, D.J., et al., Journal of the Sciences and Specialties of the Head & Neck, 2003, 25(9), 717-731), and in view of REDDELL (WO 2018/170559; provided IDS of 05/02/2025).
Determining the Scope and Contents of the Prior Art:
The reference Patent No. ‘410 is drawn to a method of treating cell proliferative disorders by administering a compound of Formula (II) (ref. claim 1), wherein species of such Formula (II) include the first and second compounds recited in instant claims 36 and 42 (ref. claim 13). Note, under the broadest reasonable interpretation (BRI), cell proliferative diseases include cancers.
The combined references BARNETT, in view of CASTRO, and in view of REDDELL teach the instant claims 24-28 and 32-43 (see ¶24 above).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach the instant compounds are administered with a second agent, cisplatin, for treatment of mucosal, subcutaneous HNSCC.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of epoxytigliane combination therapies useful for treatment of cancers such as squamous cell cancer and possesses the technical knowledge necessary to make adjustments to the drugs administered to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment of squamous cell cancer and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent No. ‘410, in view of BARNETT, in view of CASTRO, and in view of REDDELL.
The artisan would be motivated to treat mucosal, subcutaneous HNSCC with the combined treatment of either of the two cited compounds of reference claim 13 and cisplatin, in order to take advantage of the benefits taught by the combined references BARNETT, CASTRO, and REDDELL, above (¶24). The artisan would have an expectation of success in using the compounds of ‘410 since the cited compounds overlap with the compounds taught by BARNETT (Pg. 1 Right col. last ¶) and REDDELL (Pg. 14 Line 7-24 & Pg. 15 Line 1-3). Further, since the BRI of cell proliferation disorders includes cancers, the artisan would look, with an expectation of success, to references teaching treatment of cancers, including mucosal, subcutaneous HNSCC, for further use cases of the method taught by Patent No. ‘410 and would further look to improve upon the method of Patent ‘410 by the teachings of the combined references, with the same motivations as discussed in ¶24, above.
Claims 24-28 and 32-43 are rejected on the ground of obviousness type nonstatutory double patenting as being unpatentable over claims 1-3, 12, 20, and 24 of U.S. Patent No. 11,213,506 in view of BARNETT (Barnett, C.M.E., et al., Investigational New Drugs, pub. 2018, 37, 1-8; provided IDS of 05/02/2025), in view of CASTRO (Castro, D.J., et al., Journal of the Sciences and Specialties of the Head & Neck, 2003, 25(9), 717-731), and in view of REDDELL (WO 2018/170559; provided IDS of 05/02/2025).
Determining the Scope and Contents of the Prior Art:
The reference Patent No. ‘506 is drawn to a method of treating a tumor by administering a compound of Formula (I) (ref. claim 1-2), wherein species of such Formula (I) include the 10 compounds recited in instant claims 36 and 42 (ref. claim 12 & 24). The compound is administered via intratumoral injection (claim 3 & 20)
The combined references BARNETT, in view of CASTRO, and in view of REDDELL teach the instant claims 24-28 and 32-43 (see ¶24 above).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach the instant compounds are administered with a second agent, cisplatin, for treatment of mucosal, subcutaneous HNSCC.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of epoxytigliane combination therapies useful for treatment of cancers such as squamous cell cancer and possesses the technical knowledge necessary to make adjustments to the drugs administered to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment of squamous cell cancer and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent No. ‘506, in view of BARNETT, in view of CASTRO, and in view of REDDELL.
The artisan would be motivated to treat mucosal, subcutaneous HNSCC with the combined treatment of any of the 10 compounds of the reference claims and cisplatin, in order to take advantage of the benefits taught by the combined references BARNETT, CASTRO, and REDDELL, above (¶24). The artisan would have an expectation of success in using the compounds of ‘506 since the cited compounds overlap with the compounds taught by BARNETT (Pg. 1 Right col. last ¶) and REDDELL (Pg. 14 Line 7-24 & Pg. 15 Line 1-3). Further, since the Patent method is drawn to treating tumors, the artisan would look, with an expectation of success, to references teaching treatment of cancers, including mucosal, subcutaneous HNSCC, for further use cases of the method taught by Patent No. ‘506 and would further look to improve upon the method of Patent ‘506 by the teachings of the combined references, with the same motivations as discussed in ¶24, above.
Claims 42-28 and 32-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 12,208,078 in view of BARNETT (Barnett, C.M.E., et al., Investigational New Drugs, pub. 2018, 37, 1-8; provided IDS of 05/02/2025), in view of CASTRO (Castro, D.J., et al., Journal of the Sciences and Specialties of the Head & Neck, 2003, 25(9), 717-731), and in view of REDDELL (WO 2018/170559; provided IDS of 05/02/2025).
Determining the Scope and Contents of the Prior Art:
The reference Patent No. ‘078 is drawn to a method of treating a PKC-responsive cell proliferative disorder by administering 12-tigloyl-13-(2-methylbutanoyl)-6,7-epoxy-4,5,9,12,13,20-hexahydroxy-1-tigliaen-3-one (ref. claims 1-5, 8-12, 15-19, 22-26), wherein the compound is injected (ref. claim 6, 13, 20, 27) and a second agent is administered (ref. claim 7, 14, 21, 28). The cell proliferative disorder is a tumor/neoplasm (ref. claim 8) or squamous cell carcinoma (SCC) (ref. claims 15 and 22).
The combined references BARNETT, in view of CASTRO, and in view of REDDELL teach the instant claims 24-28 and 32-43 (see ¶24 above).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach the instant compounds are administered with a second agent, cisplatin, for treatment of mucosal, subcutaneous HNSCC.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of epoxytigliane combination therapies useful for treatment of cancers such as squamous cell cancer and possesses the technical knowledge necessary to make adjustments to the drugs administered to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment of squamous cell cancer and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent No. ‘078, in view of BARNETT, in view of CASTRO, and in view of REDDELL.
The artisan would be motivated to treat mucosal, subcutaneous HNSCC with the combined treatment of the compound of Patent ‘078 and cisplatin, in order to take advantage of the benefits taught by the combined references BARNETT, CASTRO, and REDDELL, above (¶24). The artisan would have an expectation of success in using the compound of ‘078 since the cited compound is the same as tigilanol tiglate/compound 1 taught by BARNETT (Pg. 1 Right col. last ¶) and REDDELL (Pg. 14 Line 7-24 & Pg. 15 Line 1-3). Further, since the reference claims treat SCC, the artisan would look, with an expectation of success, to references teaching treatment of SCC, including mucosal, subcutaneous HNSCC, for further use cases of the method taught by Patent No. ‘078 and would further look to improve upon the method of Patent ‘078 by the teachings of the combined references, with the same motivations as discussed in ¶24, above.
Claims 24-28 and 32-43 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 10-12, and 15-16 of U.S. Patent No. 12,226,391 in view of BARNETT (Barnett, C.M.E., et al., Investigational New Drugs, pub. 2018, 37, 1-8; provided IDS of 05/02/2025), in view of CASTRO (Castro, D.J., et al., Journal of the Sciences and Specialties of the Head & Neck, 2003, 25(9), 717-731), and in view of REDDELL (WO 2018/170559; provided IDS of 05/02/2025).
Determining the Scope and Contents of the Prior Art:
The reference Patent No. ‘391 is drawn to a method of treating a tumor by administering a compound of Formula (I) (ref. claim 1-2), wherein the compound is intratumorally injected (ref. claim 10-11). The tumor is squamous cell carcinoma (SCC) (ref. claims 12). The compound of Formula (I) is exemplified by 25 compounds which fall under instant Formula (I), including the same compounds 1-10 recited in instant claims 36 and 43 (ref. claims 15-16).
The combined references BARNETT, in view of CASTRO, and in view of REDDELL teach the instant claims 24-28 and 32-43 (see ¶24 above).
Ascertaining the Differences Between the Prior Art and the Claims at Issue:
The reference claims do not teach the instant compounds are administered with a second agent, cisplatin, for treatment of mucosal, subcutaneous HNSCC.
Resolving the Level of Ordinary Skill in the Pertinent Art:
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of epoxytigliane combination therapies useful for treatment of cancers such as squamous cell cancer and possesses the technical knowledge necessary to make adjustments to the drugs administered to optimize/enhance the treatment outcomes. Said artisan has also reviewed the problems in the art regarding treatment of squamous cell cancer and understands the solutions that are widely-known in the art.
Considering Objective Evidence Present in the Application Indicating Obviousness or Nonobviousness:
The instant claims are prima facie obvious in light of the combination of references Patent No. ‘391, in view of BARNETT, in view of CASTRO, and in view of REDDELL.
The artisan would be motivated to treat mucosal, subcutaneous HNSCC with the combined treatment of any one of the claimed compounds of Patent ‘391 and cisplatin, in order to take advantage of the benefits taught by the combined references BARNETT, CASTRO, and REDDELL, above (¶24). The artisan would have an expectation of success in using the compounds of ‘391 since the cited compounds are the same as compounds 1-10 taught by BARNETT (Pg. 1 Right col. last ¶) and REDDELL (Pg. 14 Line 7-24 & Pg. 15 Line 1-3). Further, since the reference claims treat SCC, the artisan would look, with an expectation of success, to references teaching treatment of SCC, including mucosal, subcutaneous HNSCC, for further use cases of the method taught by Patent No. ‘391 and would further look to improve upon the method of Patent ‘391 by the teachings of the combined references, with the same motivations as discussed in ¶24, above.
Conclusion
Claims 24-28 and 32-43 are rejected.
Note: To overcome the above 103 rejection, it is recommended Applicant provide evidence of unexpected results which are commensurate in scope with the broadest claims (see MPEP 716.02).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA ELIZABETH BELL whose telephone number is (703)756-5372. The examiner can normally be reached Monday-Friday 9:00-5:30.
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/S.E.B./Examiner, Art Unit 1625
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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