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 .
Application Status
The amendment file on 12/15/2025 in response to the Non-Final Rejection of 8/13/2025 is acknowledged and has been entered. Claims 1-5, 9-10, 12, 18-20 and 22 are currently pending and under consideration.
Information Disclosure Statement
The information disclosure statement filed on 12/15/2025 has been considered except where lined through.
Rejections Withdrawn in view of Amendments
The rejection of Claim 14 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of cancelation of claim 14.
The rejection of Claims 1-10, 13-16 and 18-21 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement is withdrawn in view of Applicants amendments.
The rejection of claim 16 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn in view of cancelation of claim 16.
Claim Objection Necessitated by amendment
Claim 12 is objected to because of the following informalities: Claim 12 list the claims in table format. Claims may contain tables either if necessary to conform to 35 U.S.C. 112 or if otherwise found to be desirable. See MPEP § 2173.05(s). When such a patent is printed, however, the table will not be included as part of the claim, and instead the claim will contain a reference to the table number.. Appropriate correction is required.
New Rejections Upon further consideration
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.
Claim(s) 1-5, 9-10, 12, 18-20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francois, Mathias (WO2018/112545A1, 2018-06-28, IDS) referred to herein as Francois in view Gramolelli et al. (Cancer Research 2020; 80(15): 3116-3129, IDS).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Francois teaches a compound of formula 1 having the structure:
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, wherein certain compounds have efficacy in the inhibition of SOX18 protein activity, and in particular with respect to the ability of SOX18 to bind DNA and/or particular protein partners (paragraphs 0007 and 0008). In particular, Francois teaches numerous compounds encompassed by formula (I) include, but not limited to,
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,
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and
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which falls within the instantly claimed compound of formula 1, wherein R3, R2, R1 and X1-X5 are H, R4 is OH, L is a C2 alkyl, C2 alkenyl, or C3 alkyl interrupted with an O (paragraph 0017). Moreover, Francois teaches a method of treating an angiogenesis or lymphangiogenesis-related disease or disorder comprising administering a therapeutically effective amount of a compound of formula (I) (paragraph 00102). With regards to the angiogenesis or lymphangiogenesis-related disease or disorder, Francois teaches this disorder include, but are not limited to, cancer such as sarcomas and lymphomas (paragraph 00112 and 00115). Lastly, Francois teaches that the SOXF group (SOX7, -17 and -18) of transcription factors (TFs) are key regulators of endothelia cell differentiation during development and are critical for the formation of vasculature, wherein mutation or deletion of SOXF gene comprises arteriovenous specification, blood vascular integrity and lymphangiogenesis, and inhibits tumor growth and metastasis in animal models of cancer (paragraph 0005).
Francois does not specifically teach that the cancer is Kaposi sarcoma caused by Kaposi sarcoma herpesvirus.
Gramolelli et al. teach that SOX18 and PROX1, central regulators of lymphatic development, are key factors for KSHV genome maintenance and lytic cycle in lymphatic endothelial cells, supporting Kaposi sarcoma tumorigenesis and representing attractive therapeutic targets (Abstract, Significance)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating angiogenesis disorders taught by Francois to include Kaposi sarcoma caused by Kaposi sarcoma herpesvirus in view of the teachings of Gramolelli et al.. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Francois teaches that the compounds are effective in treating angiogenesis related disorders such as cancer and,
- Gramolelli et al. teach that molecular targeting of SOX18 as a potential novel therapeutic avenue in Kaposi sarcoma (Abstract, Last sentence).
Claim(s) 1-5, 9-10, 12, 18-20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Francois, Mathias (WO2018/112545A1, 2018-06-28, IDS) referred to herein as Francois in in view of DiMaio and Lagunoff (Frontiers in Microbiology|Virology (2012), 3 (102)) referred to herein as DiMaio.
Francois teaches a compound of formula 1 having the structure:
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, wherein certain compounds have efficacy in the inhibition of SOX18 protein activity, and in particular with respect to the ability of SOX18 to bind DNA and/or particular protein partners (paragraphs 0007 and 0008). In particular, Francois teaches numerous compounds encompassed by formula (I) include, but not limited to,
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,
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and
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which falls within the instantly claimed compound of formula 1, wherein R3, R2, R1 and X1-X5 are H, R4 is OH, L is a C2 alkyl, C2 alkenyl, or C3 alkyl interrupted with an O (paragraph 0017). Moreover, Francois teaches a method of treating an angiogenesis or lymphangiogenesis-related disease or disorder comprising administering a therapeutically effective amount of a compound of formula (I) (paragraph 00102). With regards to the angiogenesis or lymphangiogenesis-related disease or disorder, Francois teaches this disorder include, but are not limited to, cancer such as sarcomas and lymphomas (paragraph 00112 and 00115). Lastly, Francois teaches that the SOXF group (SOX7, -17 and -18) of transcription factors (TFs) are key regulators of endothelia cell differentiation during development and are critical for the formation of vasculature, wherein mutation or deletion of SOXF gene comprises arteriovenous specification, blood vascular integrity and lymphangiogenesis, and inhibits tumor growth and metastasis in animal models of cancer (paragraph 0005).
Francois does not specifically teach that the cancer is Kaposi sarcoma caused by Kaposi sarcoma herpesvirus.
DeMaio teaches that while they differ in aggressiveness, all forms of Kaposi’s sarcoma (KS) are relatively indistinguishable at the histological, wherein grossly, the tumors have a characteristic red to purple hue which is indicative of the high vascularization of the tumor (page 1, Column 1, 2nd full paragraph). Moreover, DiMaio teaches that considering the extreme extent of angiogenesis in KS tumors at all stages it has been proposed that KSHV directly induces angiogenesis in a paracrine fashion (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method of treating angiogenesis disorders taught by Francois to include Kaposi sarcoma caused by Kaposi sarcoma herpesvirus in view of the teachings of DiMaio. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
-Francois teaches that the compounds are effective in treating angiogenesis related disorders such as cancer and,
- DiMaio teaches that considering the extreme extent of angiogenesis in KS tumors at all stages it has been proposed that KSHV directly induces angiogenesis in a paracrine fashion.
In order to expedite prosecution, the Examiner would like to respond to Applicants arguments to the previous rejection. In response to this rejection, Applicants contend that Francois does not guide the skilled artisan to make any of the specific choices to the compounds of Formula I to arrive at the claims as amended. In particular, Applicants assert that the majority of the exemplified compounds incorporate a naphthyl, rather than a phenyl at A. Assuming, for the sake of argument, that the ordinary skilled artisan could have arrived at the compounds recited in claim 1, Applicants contend that there is still no reason to select treatment of Kaposi sarcoma from among the universe of all angiogenesis or lymphangiogenesis-related diseases. In this context, Applicants assert that one of skill in the art would have recognized that Kaposi sarcoma is not an actual sarcoma at all and provides a number of references which characterize Kaposi sarcoma’s. For example, Applicants point to Coffin JM, Retroviruses. 1997 which teaches that “The lesions that characterize Kaposi’s sarcoma are not a result of neoplastic transformation of cells, but arise from an excessive proliferation of spindle cells mixed with endothelial cells, fibroblasts, and inflammatory cells, accompanied by new blood vessel formation (neoangiogenesis). Accordingly, Applicants contend that any such treatment of angiogenesis/lymphangiogenesis is not necessarily rendered as effective, or even suitable, for the treatment of Kaposi sarcoma, in view of its dual viral and inflammation pathophysiology . Applicants further contend that the method of claim 1 achieves unexpected results and points to Example 2 of the instant specification, wherein Applicant has surprisingly found that the compounds of formula 1 of claim 1 are effective in interfering with both the viral and inflammatory pathophysiologies of Kaposi sarcoma via a SOX18 mechanism of action. Accordingly, Applicants contend that none of the results from Examples 2, 3 and 4 were predictable from Francois, DeMaio, or any combination thereof.
These arguments have been carefully considered, but are not found persuasive.
In response to Applicants arguments regarding Francois, the examiner acknowledges and does not dispute Applicants contention that the majority of the exemplified compounds incorporate a naphthyl, rather than a phenyl at A. However, as set forth above, Francois specifically exemplifies compounds with SOX18 inhibitory activity which fall within the scope of the claimed invention, e.g. A is a phenyl. Regarding Applicants arguments that Kaposi sarcoma are not a typical sarcoma, the Examiner acknowledges and does not dispute that Kaposi sarcoma’s are viral driven. However, as noted by DiMaio and Coffin JM (cited by Applicants), angiogenesis is involved in Kaposi sarcoma which is the basis of the above rejection, e.g. inhibition of angiogenic disease and Applicants have not shown that angiogenesis involved with Kaposi sarcoma is different from that found in other angiogenesis and lymphangiogenesis-related cancers. Regarding Applicants arguments that any such treatment of angiogenesis/lymphangiogenesis is not necessarily rendered as effective, or even suitable, for the treatment of Kaposi sarcoma, in view of its dual viral and inflammation pathophysiology does not appear to support by any factual evidence. In contrast, it appears that treatment of Kaposi’s sarcoma is similar to many other “cancers”. For example, Lebbe et al. (European Journal of Cancer 2019; 114: 117-127) discusses various treatment options for Kaposi’s sarcoma including, but not limited to, pegylated liposomal doxorubicin, paclitaxel, vinblastine, interferon alpha-2a or 2b, as well as, antiangiogenic agents such as pomalidomidel, lenalidomide and bevacizumab (page 122, section 10). Regarding Applicants unexpected results, the Examiner has reviewed the examples within the specification and does not dispute that Applicants have discovered that the compounds of formula 1 of claim 1 are effective in interfering both the viral and inflammatory pathophysiologies of Kaposi sarcoma via a SOX18 mechanism of action. However, the Examiner recognizes that the prior art combination teaches administering the same compound to the same patient population. The fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 9-10, 12, 18-20 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-9 of copending Application No. 17/741,065 in view of in view of Gramolelli et al. (Cancer Research 2020; 80(15): 3116-3129, IDS).
The copending Application claims a compound of formula 1 having the structure:
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for use in the inhibition of a SOX18 activity (Claim 1). In particular, the copending application claims numerous compounds encompassed by formula (I) including, but not limited to,
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which falls within the instantly claimed compound of formula 1, wherein R3, R2, R1 and X1-X5 are H, R4 is OH, L is a C3 alkyl interrupted with an O (claim 9). Moreover, the specification of the copending Application teaches a method of treating an angiogenesis or lymphangiogenesis-related disease or disorder comprising administering a therapeutically effective amount of a compound of formula (I) (paragraph 00103). With regards to the angiogenesis or lymphangiogenesis-related disease or disorder, the specification of the copending Application teaches these disorder include, but are not limited to, cancer such as sarcomas and lymphomas (paragraph 00113 and 00116). Please note: The portion of the specification of the copending application that describes subject matter that falls within the scope of claim 1 may be relied upon to properly construe the scope of that claim, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)). In Sun Pharm. v. Lilly, the Court affirms this use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.
. . .
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
611 F.3d 1381, 1387 (Fed. Cir. 2010).
The copending Application does not specifically teach that the cancer is Kaposi sarcoma caused by Kaposi sarcoma herpesvirus.
Gramolelli et al. teach that SOX18 and PROX1, central regulators of lymphatic development, are key factors for KSHV genome maintenance and lytic cycle in lymphatic endothelial cells, supporting Kaposi sarcoma tumorigenesis and representing attractive therapeutic targets (Abstract, Significance)
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to use the compounds claimed by the copending Application in a method of treating Kaposi sarcoma caused by Kaposi sarcoma herpesvirus in view of the teachings of Gramolelli et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-The copending application teaches that the compounds are effective in treating angiogenesis related disorders such as cancer and,
- Gramolelli et al. teach that molecular targeting of SOX18 as a potential novel therapeutic avenue in Kaposi sarcoma (Abstract, Last sentence).
This is a provisional nonstatutory double patenting rejection.
Claims 1-5, 9-10, 12, 18-20 and 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 6-9 of copending Application No. 17/741,065 in view of DiMaio and Lagunoff (Frontiers in Microbiology|Virology (2012), 3 (102)) referred to herein as DiMaio.
The copending Application claims a compound of formula 1 having the structure:
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for use in the inhibition of a SOX18 activity (Claim 1). In particular, the copending application claims numerous compounds encompassed by formula (I) including, but not limited to,
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which falls within the instantly claimed compound of formula 1, wherein R3, R2, R1 and X1-X5 are H, R4 is OH, L is a C3 alkyl interrupted with an O (claim 9). Moreover, the specification of the copending Application teaches a method of treating an angiogenesis or lymphangiogenesis-related disease or disorder comprising administering a therapeutically effective amount of a compound of formula (I) (paragraph 00103). With regards to the angiogenesis or lymphangiogenesis-related disease or disorder, the specification of the copending Application teaches these disorder include, but are not limited to, cancer such as sarcomas and lymphomas (paragraph 00113 and 00116). Please note: The portion of the specification of the copending application that describes subject matter that falls within the scope of claim 1 may be relied upon to properly construe the scope of that claim, including all of the composition’s disclosed uses or utilities. (MPEP 804(II)(B)(1)). In Sun Pharm. v. Lilly, the Court affirms this use of the specification and states,
A ‘claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use,’ extends to any and all such uses disclosed in the specification of the earlier patent.
. . .
[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . . and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted.
611 F.3d 1381, 1387 (Fed. Cir. 2010).
The copending Application does not specifically teach that the cancer is Kaposi sarcoma caused by Kaposi sarcoma herpesvirus.
DeMaio teaches that while they differ in aggressiveness, all forms of Kaposi’s sarcoma (KS) are relatively indistinguishable at the histological, wherein grossly, the tumors have a characteristic red to purple hue which is indicative of the high vascularization of the tumor (page 1, Column 1, 2nd full paragraph). Moreover, DiMaio teaches that considering the extreme extent of angiogenesis in KS tumors at all stages it has been proposed that KSHV directly induces angiogenesis in a paracrine fashion (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to use the compounds claimed by the copending Application in a method of treating Kaposi sarcoma caused by Kaposi sarcoma herpesvirus in view of the teachings of DeMaio. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-The copending application teaches that the compounds are effective in treating angiogenesis related disorders such as cancer and,
- DiMaio teaches that considering the extreme extent of angiogenesis in KS tumors at all stages it has been proposed that KSHV directly induces angiogenesis in a paracrine fashion.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Therefore, NO claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626