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 .
Claim Status
Claims 1-15 are pending. Claims 1-15 are rejected.
Claim Objections
Claims 2 and 14 are objected to because of the following informalities:
The second to last compound on page 3 of claim 4 reads:
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“naptalene” should read “naphthalene”.
Claim 14 recites “22-(4-methylpiperazin-1-yl)-N-(4-(3-((4- pentylphenyl)sulfonamido)phenyl)thiazol-2-yl)acetamide”. The compound should read “2-(4-methylpiperazin-1-yl)-N-(4-(3-((4-pentylphenyl)sulfonamido)phenyl)thiazol-2-yl)acetamide”.
Appropriate correction is required.
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 4-5, 12 and 14 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.
Claims 4-5, 12 and 14 are broader in scope than claim 1 from which they depend. Each of the claims recites compounds that are not embraced by instant formula (I) such as
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and
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The exemplary compounds contain moieties other than: R2 selected from H, halogen or OR6; and the following core sulfonamide
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, neither of which is provided for in instant claim 1.
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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by MILLET ET AL: "Discovery and Optimization of N-(4-(3-Aminophenyl)thiazol-2-yl)acetammide as a Novel Scaffold Active against Sensitive and Resistant Cancer Cells", JOURNAL OF MEDICINAL CHEMISTRY, vol. 59, no. 18, p. 8276-8292, 2016-09-22. (cited in the IDS filed 06/19/2024).
The prior art discloses compound 5t represented below (page 8279, Table 1):
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The prior art compound reads on instant claims 1 and 3 and is embraced by instant formula (I) where R1 is 4-pentylphenyl, R2 is H, R3 is NR4R5, R4 is H, R5 is COR7, and R7 is C1 alkyl.
Claim(s) 1-2, 6-7, 9-11 and 15 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2014072486 A1 by Rocchi et al. (cited in the IDS filed 06/19/2024).
The prior art discloses compound HA15 shown below (page 27):
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The prior art compound reads on instant claims 1-2, 6-7, 9-11 and 15 and is embraced by instant formula (I) where R1 is 5-(dimethylamino)naphthalene, R2 is H, R3 is NR4R5, R4 is H, R5 is COR7, and R7 is C1 alkyl.
Regarding the methods of treating cancer recited in instant claims 6-7, 9-11 and 15, the prior art discloses in vivo treatment of melanoma in mice wherein compound HA15 is administered (page 36, lines 20-32).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 1-2, 6-7, 9-11 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2014072486 A1 by Rocchi et al. (cited in the IDS filed 06/19/2024)
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
The prior teaches benzene sulfonamide compounds including compound HA15 shown below (page 27):
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The prior art compound reads on instant claims 1-2, 6-7, 9-11 and 15 and is embraced by instant formula (I) where R1 is 5-(dimethylamino)naphthalene, R2 is H, R3 is NR4R5, R4 is H, R5 is COR7, and R7 is C1 alkyl.
Regarding the methods of treating cancer recited in instant claims 6-7, 9-11 and 15, the prior art discloses in vivo treatment of melanoma in mice wherein compound HA15 is administered (page 36, lines 20-32). Additionally, the prior art teaches that the prior art compounds are useful for other cancers such as prostate, breast and colon cancers (page 2, lines 10-12).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
Prior art compound HA15 reads on instant claims 1-2, 6-7, 9-11 and 15 and was administered for the treatment of melanoma. Rocchi et al. further teach that the prior art compounds are useful for prostate, breast and colon cancers but does not disclose methods wherein the compound is administered to subjects with these conditions.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
A person of ordinary skill seeking to treat additional subjects with solid cancers would have been motivated to test treatment methods compromising administering prior art compound HA15 to treat prostate, breast and colon cancers as suggested by Rocchi et al.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2014072486 A1 by Rocchi et al. as applied to claims 1-2, 6-7, 9-11 and 15 above, and further in view of Cerezo et al. (2017) New anti-cancer molecules targeting HSPA5/BIP to induce endoplasmic reticulum stress, autophagy and apoptosis, Autophagy, 13:1, 216-217.
Rocchi et al. disclose compound HA15 and state “the compounds of the invention are also efficient on several other cancers namely prostate, breast and colon indicating that these molecules may be active in all type of cancers” (page 2, lines 10-12). However, the reference is silent to the use of the compound for treating liquid cancers such as leukemia.
Cerezo et al. discuss (title) “New anti-cancer molecules targeting HSPA5/BIP to induce endoplasmic reticulum stress, autophagy and apoptosis” and teach the following about HSPA5 (page 216):
Neoplastic growth requires synthesis of a significant quantity of new proteins. In this condition, the UPR is hyperactivated to deal with the high flux of proteins processed through the ER and to maintain ER homeostasis. One of the key proteins involved in UPR is HSPA5/GRP78/BiP. Indeed, in addition to fulfilling the function of a protein chaperone, HSPA5 is also considered to be a master regulator of the UPR.
Regarding the use of compound HA15 for cancers other than melanoma, Cerezo et al. reports (page 217):
Finally, we have tested if targeting HSPA5 to induce ER stress could be a useful strategy in the treatment of other forms of cancer types. To examine this possibility, we used a panel of solid and liquid tumors. Interestingly, we have observed that HA15 treatment induced ER stress, autophagy and apoptosis in all the tested cell lines including ImaR, an acute myeloid leukemia cell line, and MiaPaca, a pancreas cancer cell line, which are resistant to the classical therapies using Imatinib and Gemcitabin, respectively.
Accordingly, person of ordinary skill seeking to treat additional subjects with compound HA15 of Rocchi et al. and Cerezo et al. would have been motivated to test treatment methods compromising administering prior art compound HA15 to subjects with a liquid cancer such as acute myeloid leukemia as the compound was capable of inducing apoptosis as taught by Cerezo et al.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2014072486 A1 by Rocchi et al. and Cerezo et al. (2017) New anti-cancer molecules targeting HSPA5/BIP to induce endoplasmic reticulum stress, autophagy and apoptosis, Autophagy, 13:1, 216-217. as applied to claims 1-2, 6-11 and 15 above, and further in view of Fu et al. Int J Biol Sci 2021; 17(3):897-910.
Rocchi et al. disclose compound HA15 and state “the compounds of the invention are also efficient on several other cancers namely prostate, breast and colon indicating that these molecules may be active in all type of cancers” (page 2, lines 10-12). Cerezo et al. disclose that compound HA15 is useful for targeting HSPA5 to induce ER stress could be a useful strategy in the treatment of cancers such as acute myeloid leukemia and pancreatic cancer (page 217). However, the references are silent to the use of the compound for treating other solid cancers such as esophageal cancer.
Fu et al. provide an “Evaluation and characterization of HSPA5 (GRP78) expression profiles in normal individuals and cancer patients with COVID-19” (title) and report the following regarding HSPA5 expression in malignant cancers (page 902):
3.5. The expression of HSPA5 is higher in malignant tumors than that in matched normal samples.
Then, we compared to the HSPA5 mRNA expression profile across all tumor samples and their paired normal tissues in 31 types of cancers using the GEPIA dataset. The results showed that all cancer tissues can express HSPA5, and the highest expression levels were noticed in thyroid carcinoma (Fig. 4A&B). The expressions of HSPA5 were significantly increased in 14 types of cancers, including cholangiocarcinoma (CHOL), colon adenocarcinoma (COAD), lymphoid neoplasm diffuse large B-cell lymphoma (DLBC), esophageal carcinoma (ESCA), glioblastoma multiforme (GBM), brain lower grade glioma (LGG), pancreatic adenocarcinoma (PAAD), prostate adenocarcinoma(PRAD), rectum adenocarcinoma (READ), skin cutaneous melanoma (SKCM), stomach adenocarcinoma (STAD), thymoma, uterine corpus endometrial carcinoma (UCEC), and uterine carcinosarcoma (UCS) (Fig. 4C, p<0.01)
Accordingly, person of ordinary skill seeking to treat additional subjects with compound HA15 of Rocchi et al. and Cerezo et al. would have been motivated to test treatment methods compromising administering prior art compound HA15 to subjects with cancers characterized as having increased HSPA5 expression such as esophageal carcinoma disclosed by Fu et al. as compound HA15 was useful for targeting HSAP5 to induce apoptosis in other cancer types taught by Cerezo et al.
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 1-2, 6-7, 9-11 and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,567,310 in view of WO 2014072486 A1 by Rocchi et al.
Claim 1 of the patent discloses a method of treating a cancer selected from melanoma, prostate cancer, breast cancer and colon cancer by administering a compound of formula (I) shown below (Col. 34):
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Rocchi et al. disclose benzene sulfonamide compounds including compound HA15 shown below (page 27):
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The prior art compound reads on instant claims 1-2, 6-7, 9-11 and 15 and is embraced by instant formula (I) where R1 is 5-(dimethylamino)naphthalene, R2 is H, R3 is NR4R5, R4 is H, R5 is COR7, and R7 is C1 alkyl. Additionally, compound HA15 is embraced by patent formula (I) where R1 is naphthyl substituted by NR6R7 where R6 and R7 are alkyl, R2 is R6 which is H, each of Q1 to Q5 is CR6 where R6 is H, R5 is R6 which is H, R3 is R6 which is H and R4 is COR8 where R8 is alkyl.
Regarding the methods of treating cancer recited in instant claims 6-7, 9-11 and 15, Rocchi et al. also disclose in vivo treatment of melanoma comprising administration of the compound above (page 36, lines 20-32).
The instant claims are obvious over the claims of patent for the same reasons as recited in view of Rocchi et al. because the patent and prior art reference overlap in such a manner that cancer treatment comprising administration of compound HA15 is embraced by both.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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