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 . Claims 1-9 filed August 04, 2024 are currently pending.
Priority
Acknowledgement is made of the national stage entry of PCT/IB2023/051527 filed 02/20/2023, which claims priority to foreign application 117807 filed 02/22/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/15/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following grammatical informalities: Claim 1 recites the neoplastic disorders of “colorectal cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer and ovarian and endometrial cancer in an individual”. Appropriate correction to “colorectal cancer, pancreatic ductal adenocarcinoma, non-small cell lung cancer,
Claim Rejections - 35 USC § 112-Paragraph 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 3 and 5 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.
Regarding claims 3 and 5, the phrase “in particular” or "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention, or the intended scope of the claim See MPEP § 2173.05(d). In the present case, the metes and bounds of claim 3 are unclear as to whether any mammal reads on the limitation of the present claims, or in the alternative, administration of the organometallic ruthenium compound of claim 1 must be to a human. Regarding claim 5, the metes and bounds of claim 5 are unclear as to whether oral or rectal administration of the organometallic ruthenium compound of claim 1 reads on the present claims, or in the alternative, parenteral administration of the organometallic ruthenium compound of claim 1 is required.
Accordingly, one of ordinary skill in the art prior to the time of the invention would not have been reasonably apprised of the metes and bounds of the subject matter for which Applicant was presently seeking protection.
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Moreira (European Journal of Medicinal Chemistry Vol. 168 pages 373-384. Published 2019).
Moreira teaches compound Ru1, which reads on presently claimed organometallic ruthenium compound Formula (I) wherein A is the triflate salt. (page 375, Figure 2).
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As shown in Table 1, Moreira teaches that said Ru1 is efficacious at inhibiting A2780 ovarian cancer cell tumorigenesis (page 375, Table 1). Regarding claims 4 and 7, Moreira teaches formulating said Ru1 in a pharmaceutically acceptable excipient of DMSO, wherein the composition is in the form of a solution (page 380 right col.).
Regarding the claimed limitation directed to use of the composition of Formula (I) wherein it is administered via oral, rectal or parenteral route (claims 5-6) such a limitation of the instant claims fails to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the composition (i.e., an intent to use the disclosed composition as treatment and intent to administer said composition) which does not impart any physical or material characteristics to the composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble of not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP §2112.02(11). In the instant case, the cited prior art Ru1 composition of Moreira formulated in DMSO meets each and every structural and physical limitation of the instantly claimed composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the composition of the prior art and that of the instant claims.
Lastly, regarding the limitation wherein the administered Ru1 inhibits KRAS and downstream signaling pathways MAPK and PI3K (claims 8-9), Applicant is reminded of MPEP 2112.01 wherein “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). Thus, the burden is shifted to the applicant to show that the prior art product Ru1 of Moreira does not inherently possess the same properties as the instantly claimed product.
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.
Claim(s) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Moreira (European Journal of Medicinal Chemistry Vol. 168 pages 373-384. Published 2019) and Anselmo Viegas Garcia (WO2016/087932 published 06/09/2016).
Moreira teaches compound Ru1, which reads on presently claimed organometallic ruthenium compound Formula (I) wherein A is the triflate salt. (page 375, Figure 2).
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As shown in Table 1, Moreira teaches that said Ru1 is efficacious at inhibiting A2780 ovarian cancer cell tumorigenesis (page 375, Table 1). Regarding claims 4 and 7, Moreira teaches formulating said Ru1 in a pharmaceutically acceptable excipient of DMSO, wherein the composition is in the form of a solution (page 380 right col.).
The difference between the organometallic ruthenium compound Ru1 of Moriera and that of the present claims that Moreira does not specifically teach wherein the compound is administered via a parenteral route, such as intravenous administration.
Anselmo Viegas Garcia (WO2016/087932 published 06/09/2016) teach organometallic ruthenium compounds of Formula (V) and (VI) wherein said compound of Formula (V) and (VI) comprise a bis(2-{2-(2-hydroxypropanoyloxy)-poly(lactic acid) ester appending the bi-pyridine ligand instead of a bis-4-methyoxy-pyridine ligand of Ru1 (abstract, pages 14-15). Anselmo Viegas Garcia teaches said organometallic ruthenium compounds are also efficacious at inhibiting A2780 ovarian cancer cell tumorigenesis (page 8, page 40-42, Figures 5a, page 31, Claims 1, 22-23). Anselmo Viegas Garcia additionally teaches formulation of said compounds as a liquid solution for intraperitoneal or intravenous administration to a mammalian neoplastic patient in a xenograft animal model (pages 3-4, 40-42, page 45, claims 1, 23-25).
Therefore, one of ordinary skill in the art prior to the time of the invention, knowing that the organometallic ruthenium compound Ru1, formulated as a liquid solution in DMSO is efficacious at inhibiting A2780 ovarian cancer cell tumorigenesis in a subject as taught by Moreira, said skilled artisan would have found it prima facie obvious to administer said chemotherapeutic via intravenous administration to an ovarian cancer patient in view of Anselmo Viegas Garcia, arriving at the presently claimed.
MPEP 2143 provides rationale for a conclusion of obviousness including (A): Combining prior art elements according to known methods to yield predictable results;
In the present case, it was known in the prior art of Anselmo Viegas Garcia to administer A2780-ovarian cancer treating organometallic ruthenium compounds as liquid solutions via intravenous or intraperitoneal administration to treat neoplastic patients in need. Consistent with this reasoning, it would have been obvious to have selected the intravenous administration techniques for A2780-ovarian cancer treating organometallic ruthenium compounds from within the prior art of Anselmo Viegas Garcia above and apply it to the A2780-ovarian cancer treating organometallic ruthenium compound Ru1 of Moreira, arriving at the claimed methodology “yielding no more than one would expect from such an arrangement”.
Regarding the limitation wherein the administered Ru1 inhibits KRAS and downstream signaling pathways MAPK and PI3K (claims 8-9), Applicant is reminded of MPEP 2112.01 wherein “Products of identical chemical composition can not have mutual exclusive properties.” Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). Thus, the burden is shifted to the applicant to show that the prior art product Ru1 of Moreira does not inherently possess the same properties as the instantly claimed product.
Conclusion
In view of the rejections above, no claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GEORGE W KOSTURKO whose telephone number is (571)270-5903. The examiner can normally be reached M-F 9:00-5:30.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
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