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 .
DETAILED ACTION
Response to Amendment
The amendment filed 6/05/2026 has been entered. Newly amended Claims 27, 30, 33-34, and 43-59 are pending in the application. Applicant’s amendments to the Claims have overcome every rejection previously set forth in the Non-Final Office Action mailed 2/26/2026.
**The status of Claims 31-32 are not recorded in the latest-filed claim set. However, applicant indicates in arguments that said claims are canceled. The status of the claims is interpreted as such.**
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Response to Applicant’s Arguments
Applicant’s arguments are moot following amendment. New rejections are issued below not contingent on said arguments.
Claim Objections
Claim 50 is objected to because “oesophagus” should be spelled using the standard American spelling “esophagus”.
Claims 53 is objected to because “The method of Claim 27,” is repeated.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claims 57-59 are 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 regards as the invention.
Claims 57-59 depend on Claim 55 rather than Claim 56. Claim 56 appears to be the independent claim from which Claims 57-59 appropriately limit the scope. It is further unclear how R groups which are not depicted in Claim 55 or 49 are meant to be interpreted in Claim 57, for example. For the purpose of compact prosecution, Claims 57-59 are interpreted to be dependent on independent Claim 56 wherein R groups and both types of cancer individually claimed in Claims 58-59 are present.
Claim Rejections - 35 USC § 112(d)
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 53 and 57-59 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 53 recites “cancer is a tumor with or without microsatellite instability”. A cancer can either have or not have MSI. Therefore, the genus encompassing both alternatives is not further limiting. With respect to the limitation “tumor”, “tumor” is not interpreted to mean exclusively solid tumors but also include hematological tumors, both classes comprising all cancers. Applicant may clarify on the record that “tumor” is somehow limiting to overcome the rejection. Further, applicant may separate the “with” and “without” limitations into separate claims to further limit the scope of Claim 27 upon which Claim 53 depends.
Claims 57-59 are dependent on Claim 55. Claim 55 recites a particular cancer, CRC, and is dependent on Claim 49 which is a single compound with no variable R groups. Claim 57 recites R groups, expanding the scope of acceptable compounds to be administered. Claim 58 recites an entirely different cancer than that of Claim 55, constituting a mutually exclusive claim scope. Claim 59 recites the same cancer type as 55, therefore not limiting the claim scope of Claim 55.
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.
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.
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.
Claims 56-57 and 59 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson (Journal of Medicinal Chemistry. 2012, 55, 7706-7718) in view of Zhao (Int J Clin Exp Pathol 2016;9(2):1829-1838) and Li (World J Gastroenterol 2015 January 7; 21(1): 84-93).
Andersson teaches ADP-ribosyltransferases or ARTDs are useful in DNA repair and remodeling and inhibitors of ARTDs, specifically ARTD1/2, are known for the treatment of cancers. Andersson teaches Compound 17 as a potential ARTD8 binder (Page 7710, Table 1; Page 7711, Figure 5):
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in which the following definitions of examined Formula II apply: R1, R2, R3, R4, R6, and R7 are H; R5 is Me, an unsubstituted alkyl; X is sulfur; and n is 2. Andersson teaches the specific role and function of ARTD8, specifically, is not known (Abstract).
Zhao teaches ARTD8 is elevated in colorectal cancer (CRC) and multiple myeloma (Page 1831-1833):
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“ARTD8 probably participate in the progression of colorectal carcinoma” (Page 1833, Para 2). Further, “The expression of ARTD8 has been seen in various tumor tissues including B-cell lymphomas, hepatocellular carcinoma, and multiple myeloma.” (Page 1833, Para 2).
Zhao does not teach a relationship between p53 and CRC.
Li teaches “[i]t is generally known that the progression of CRC follows mutations of the APC, K-Ras, and p53 genes. p53 is the most commonly mutated gene in human cancers” and “p53 mutation in CRC occurs in 34% of the proximal colon tumors, and in 45% of the distal colorectal tumors” (Page 87, P53 MUTATION…).
Therefore, one of skill in the art seeking to treat common forms of CRC with mutant p53 variants as taught in Li, including progressed variants wherein p53 and KRAS are mutated, would find it obvious to use an ARTD8 inhibitor like Compound 17 taught in Andersson to treat said disease because Zhao suggests ARTD8 inhibitors are effective for the treatment of cancers with elevated ARTD8 like CRC. The same artisan before the effective filing date of the instant claims would have reasonably expected the effective treatment of the mutated cancer using the Andersson compound because mutant-p53 CRC commonly expresses increased ARTD8 as a characteristic of its pathology.
Claims 56-58 are rejected under 35 U.S.C. 103 as being unpatentable over Andersson (Journal of Medicinal Chemistry. 2012, 55, 7706-7718) in view of Zhao (Int J Clin Exp Pathol 2016;9(2):1829-1838) and Neri (Blood, Vol 81, No 1 (January 1). 1993: pp 128-135).
Andersson teaches ADP-ribosyltransferases or ARTDs are useful in DNA repair and remodeling and inhibitors of ARTDs, specifically ARTD1/2, are known for the treatment of cancers. Andersson teaches Compound 17 as a potential ARTD8 binder (Page 7710, Table 1; Page 7711, Figure 5):
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in which the following definitions of examined Formula II apply: R1, R2, R3, R4, R6, and R7 are H; R5 is Me, an unsubstituted alkyl; X is sulfur; and n is 2. Andersson teaches the specific role and function of ARTD8 is not known (Abstract).
Zhao teaches ARTD8 is elevated in colorectal cancers and multiple myeloma (MM) (Page 1831-1833):
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“It suggested that ARTD8 probably participate in the progression of colorectal carcinoma” (Page 1833, Para 2). Further, “The expression of ARTD8 has been seen in various tumor tissues including B-cell lymphomas, hepatocellular carcinoma, and multiple myeloma… ARTD8 is highly expressed in myeloma plasma cells and there also has a correlation of ARTD8 expression with disease progression and poor survival in multiple myeloma.” (Page 1833).
Zhao does not teach a relationship between p53 and MM.
Neri teaches plainly “p53 mutations are frequently found in patients with MM and are associated with the more advanced (acute/leukemic) forms of the disease” (Page 128, Right Col).
Therefore, one of skill in the art seeking to treat frequently found forms of MM with mutant p53 variants, including advanced variants forms which share increased p53 mutation and ARTD8 expression, would find it obvious to use an ARTD8 inhibitor like Compound 17 taught in Andersson to treat said disease because Zhao suggests ARTD8 inhibitors are effective for the treatment of cancers with elevated ARTD8 like MM. The same artisan before the effective filing date of the instant claims would have reasonably expected the effective treatment of the mutant cancer using the Andersson compound because MM expressing increased ARTD8 as a characteristic of its pathology is frequently a p53 mutant. One of skill in the art would also be more eager to attempt this therapeutic route because p53 mutations, like ARTD8, are “associated with the more advanced” forms.
Conclusion
Claims 53 and 56-59 are rejected. Claim 53 is objected to. Claims 27, 30, 33-34, 43-52, and 54-55 are allowable.
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 extension fee 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.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 7:30am - 4:30pm.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627
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