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
Election of Species and Status of the Claims
Applicant’s election without traverse of ‘XZ664p’ as the single specific compound in the response filed on April 28th 2026 is acknowledged. Claims 1, 4-6, 20, 28, 31, 33, 55, 63-64, 66, and 106-113 are pending. Claim 28 is withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 1, 4-6, 20, 31, 33, 55, 63-64, 66, and 106-113 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statement filed on July 25th 2023 is in compliance with the provisions of 37 CFR 1.97 and has been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 108-113 are rejected 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. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite the following limitations:
Claim 108: “wherein at least one R1 substituent, at least one R2substituent, and/or at least one R3 substituent is -COOH, -CHO, -CONH2, -SO3H, -SO2F, -OSO2F, -SO2(C1-C2alkyl) CO2H, -PO3H, -PO2(C1-C2alkyl), -PO2NH(C1-C2alkyl), -(C1-C2alkyl) PO3H, or -(C1-C2alkyl) PO2NH(C1-C2alkyl)”
Claim 109: “wherein at least one R1 substituent is -COOH; and at least one R2 substituent is other than H”
Claim 110: ““wherein at least one R1 substituent is -COOH; and at least one R2 substituent is phenyl”
Claim 111: “wherein at least one R1 substituent is -COOH, -CHO, -CONH2, -SO3H, -SO2F, -OSO2F, -SO2(C1-C2alkyl) CO2H, -PO3H, -PO2(C1-C2alkyl), -PO2NH(C1-C2alkyl), -(C1-C2alkyl) PO3H, or -(C1-C2alkyl) PO2NH(C1-C2alkyl); and at least R2 substituent is other than H”
Claim 112: “wherein at least one R1 substituent is -COOH, -CHO, -CONH2, -SO3H, -SO2F, -OSO2F, -SO2(C1-C2alkyl) CO2H, -PO3H, -PO2(C1-C2alkyl), -PO2NH(C1-C2alkyl), -(C1-C2alkyl) PO3H, or -(C1-C2alkyl) PO2NH(C1-C2alkyl); and at least R2 substituent is phenyl”
Claim 113: “provided that when X is N, at least one R2 substituent is other than H”
Support for none of the above limitations is found in the specification, and said limitations are thereby considered new matter.
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 1, 5, 6, and their dependent claims 55, 63, 64, 66, and 106-112 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 5, 6, and their dependent claims 55, 63, 64, 66, and 106-112 are indefinite for their references to Table 4. See MPEP 2173.05(s):
Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).
Claim Rejections - 35 USC § 102
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 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.
Claims 1, 4-5, 20, 31, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (KR2016001508 A published on January 6th 2016).
Claims 1, 4-5, 20, 31, and 33 are directed towards a compound of Formula I:
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Kim teaches the compound,
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(Kim, pg. 37),
which is anticipatory of claims 1, 4-6, 20, 31, 33, and 113.
Claims 1, 4-5, 20, 31, and 33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Klein (U.S. Patent No. 8,153,649 issued on April 10th 2012).
Claim 106 and 107 are directed towards the compound of claim 1, wherein X is C and at least one of R1-3 is COOH.
Klein teaches the compound,
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(Klein, col. 30),
which anticipates claims 1, 106, and 107.
Claims 1, 55, 64, and 66 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farkas (WO2010/116302 A1 published on October 14th 2010).
Claims 55 and 63 are directed towards a method of treating TDP1 expressing cancer in a patient via administration of a compound of claim 1. It is noted that the patient population expressed in the claim is not limited in scope to any population other than “a patient.” As such, the treatment method described is applicable to all patients with or without the described ailment (cancer), and any resulting effects from said treatment would be inherent in the administration. See MPEP 211.02:
"[A] claim preamble has the import that the claim as a whole suggests for it." Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620, 34 USPQ2d 1816, 1820 (Fed. Cir. 1995). "If the claim preamble, when read in the context of the entire claim, recites limitations of the claim, or, if the claim preamble is ‘necessary to give life, meaning, and vitality’ to the claim, then the claim preamble should be construed as if in the balance of the claim." Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165-66 (Fed. Cir. 1999). See also Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333, 68 USPQ2d 1154, 1158 (Fed. Cir. 2003) (In considering the effect of the preamble in a claim directed to a method of treating or preventing pernicious anemia in humans by administering a certain vitamin preparation to "a human in need thereof," the court held that the claims’ recitation of a patient or a human "in need" gives life and meaning to the preamble’s statement of purpose.). Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951) (A preamble reciting "[a]n abrasive article" was deemed essential to point out the invention defined by claims to an article comprising abrasive grains and a hardened binder and the process of making it. The court stated "it is only by that phrase that it can be known that the subject matter defined by the claims is comprised as an abrasive article. Every union of substances capable inter alia of use as abrasive grains and a binder is not an ‘abrasive article.’" Therefore, the preamble served to further define the structure of the article produced.).
Farkas teaches the treatment of treating colon cancer (Farkas, claim 14) with the compound,
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(Farkas, claim 21).
Thus, the treatment method of Farkas shares a patient population with applicant’s claims 55 and 64 (i.e. a patient), and Farkas anticipates claims 1, 55, and 64.
Claim 66 is directed towards a method of degrading TDP1 in a patient via administration of a compound of claim 1. The patient population of claim 66 is likewise directed towards “a patient,” and Farkas anticipates claim 66 for the same reasons as claims 55 and 63.
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 63 is rejected under 35 U.S.C. 103 as being unpatentable over Farkas in view of Gilbert (Gilbert et al., Topoisomerase I inhibition in colorectal cancer: biomarkers and therapeutic targets. Br J Cancer 106, 18–24 (2012)).
Claim 63 is directed towards the method of claim 55 wherein the compound is administered alongside a topoisomerase I inhibitor. Farkas teaches a method of treating colon cancer via administration of a compound of claim 1 (see the above 102 rejection of claim 55). Farkas does not explicitly teach treatment alongside a topoisomerase I inhibitor, but one of ordinary skill in the art would have had a reasonable expectation of success in administering Farkas’ compound alongside a topoisomerase I inhibitor, because such inhibitors are known in the art to be used to treat colon cancer. See Gilbert, who teaches the treatment of colon cancers with topoisomerase I inhibitors, including irinotecan (Gilbert, pg. 106-107). As both compounds are known in the art for the treatment of colon cancer, one of ordinary skill in the art would reasonably perform a combination treatment of colon cancer comprising the two compounds. See MPEP 2144.06(I):
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
Claim 63 is thereby prima facie obvious.
Allowable Subject Matter
Claim 6 is free of the prior art. Applicant has developed Tyrosil-DNA phosphodiesterase 1 inhibitors of the generic formula:
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Compounds from applicant’s generic genus are found scattered through the art, including art as diverse as the semiconductor field (See Kim; KR2016001508 A published on January 6th 2016), which incidentally includes compounds of the generic genus.
The sodium glucose cotransporter inhibitors of Klein (U.S. Patent No. 8,153,649 issued on April 10th 2012) are relevant, but the only structures anticipatory of applicant’s generic genus are intermediates, who could not be modified to get applicant’s TDP1 inhibitors from known methods in the art. The anticancer compounds taught in Farkas (WO2010/116302 A1 published on October 14th 2010) are additionally anticipatory of the compound genus.
Claim 6 is 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
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