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 .
Formal Matters
Claims 1-16 were originally presented on 10/20/2023. The preliminary amendments to the claims, also filed on 10/20/2023, have been received and entered. Claims 11-13 were cancelled and claims 17-18 newly added.
Claims 1-10 and 14-18 are pending and under examination.
Priority
This application is a 371 of PCT/SG2022/050251, filed 04/27/2022, which claims priority to foreign application 10202104429U, filed in Singapore on 04/29/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
Applicant’s Information Disclosure Statements filed 10/20/2023 and 12/07/2023 have been received and entered into the present application. As reflected by the attached, completed copies of form PTO-1449, the Examiner has considered the cited references to the extent that they comply with the provisions of 37 C.F.R. §1.97, §1.98 and MPEP §609.
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.
"The primary purpose of this requirement of definiteness of claim language is to ensure that the scope of the claims is clear so the public is informed of the boundaries of what constitutes infringement of the patent. A secondary purpose is to provide a clear measure of what applicants regard as the invention so that it can be determined whether the claimed invention meets all the criteria for patentability and whether the specification meets the criteria of 35 U.S.C. 112, first paragraph with respect to the claimed invention.", (see MPEP § 2173).
Claims 14-16 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.
Claim 14 recites a method of treatment of cancer which comprises the administration of an effective amount of a compound of formula I or a pharmaceutically acceptable salt or solvate thereof, as defined in Claim 1.
The metes and bounds of the claims are unclear because no subject population is recited in claim 14 or any claim dependent therefrom. As such, it is entirely unclear to whom or what the compound of formula I or a pharmaceutically acceptable salt or solvate thereof, as defined in Claim 1 is being administered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6 and 10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
The claim(s) recite(s) compounds of formula I:
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where R1 and R2 each independently represent H, -C(O)R3 or -C(O)C1-6 alkyl, which latter group is unsubstituted or substituted by one or more groups selected from halo and R4, or R1 represents -C(O)R3 or -C(O)C1-6 alkyl, which latter group is unsubstituted or substituted by one or more groups selected from halo and R4, and R2 represents -C(O)C(=CH2)CH3. See Claim 1. Applicants define the term “alkyl” to refer to an unbranched or branched, acyclic or cyclic, saturated or unsaturated (so forming, for example, an alkenyl or alkynyl) hydrocarbon radical (Specification at p.22, l.14-16). As such, the moiety -C(O)C(=CH2)CH3 is also a -C(O)C1-6 alkyl as defined in claim 1. The claims therefore read on molephantin, which is a compound of Formula I wherein R1 is H and R2 is -C(O)C1-6 alkyl (C3 branched, acyclic, unsaturated alkyl). Applicants admit that molephantin is a product of nature. See Specification at p.2, l.21-22 (“[t]he invention relates to derivatives of molephantin, which itself my be isolated from E.tomentosus L.”). Such is also evidenced by LEE ET AL. (Journal of Pharmaceutical Sciences, 1980, vol. 69, no. 9, p.1050-1056), who teach extracting and isolating the natural product molephantin from Elephantopus mollis (Abstract; Compound I).
This judicial exception is not integrated into a practical application because the claims literally encompass the natural product molephantin. Applicant’s claims would preclude from the public any and all compositions and uses of the natural product molephantin. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because no other additional elements are recited in the claims. Regarding claim 10, which requires a pharmaceutical composition including a compound of formula I, e.g., molephantin, in admixture with a pharmaceutically acceptable carrier, such encompasses simple mixing of molephantin with water or ethanol, which themselves are also products of nature. This too, would preclude from the public any and all biological testing/screening of the natural product molephantin.
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 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) 1-6, 10, 14-15, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LEE ET AL. (Journal of Pharmaceutical Sciences, 1980, vol. 69, no. 9, p.1050-1056).
Regarding claims 1-6 and 18, LEE ET AL. teach compounds I and Ia:
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(p.1050, right column). Compound I is molephantin, which is a compound of the claimed formula I wherein R1 is H and R2 is -C(O)C1-6 alkyl (C3 alkyl).1 Compound Ia is a compound of the claimed formula I wherein R1 is -C(O)C1-6 alkyl (-CH3) and R2 is -C(O)C(=CH2)CH3. Regarding claims 10 and 14-15, they teach Compound I, i.e., molephantin, has antitumor activity against Ehrlich Ascites carcinoma, Walker 256 Carcinoma, and P-388 lymphocytic leukemia when administered in vivo (Table I).
Claim(s) 1-6, 10, and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 01/58888 A1 (Published August 16, 2001).
Regarding claims 1-6 and 18, WO ‘888 teaches compound 13:
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(p.15, Compound 13; Example 11; Claim 6). Compound 13 is a compound of the claimed formula I wherein R1 is -C(O)C1-6 alkyl (-CH3) and R2 is -C(O)C(=CH2)CH3. WO ‘888 also teaches Compound 1, i.e., molephantin, as a compound of its invention having antiprotozoal activity:
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(p.5-6). Molephantin is a compound of the claimed formula I wherein R1 is H and R2 is -C(O)C1-6 alkyl (C3 alkyl).2 Regarding claim 10, WO ‘888 teaches pharmaceutical composition comprising a compound taught therein and a pharmaceutically acceptable adjuvant, diluent, or carrier (p.16; p.26-27, p.42-43).
Claim(s) 1-5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by STN Accession NO. 1214983-64-8 (Chemical Abstract Services, Database Registry, March 26, 2010).
Regarding claims 1-5, the database registry for STN Accession NO. 1214983-64-8 teaches a compound having the following chemical structure:
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(p.1). This is a compound of the claimed formula I wherein R1 is -C(O)C1-6 alkyl (C4 alkyl, i.e., -C(CH3)=CHCH3) and R2 is H.
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 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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-6, 10, 14-16, and 18 are rejected under 35 U.S.C. 103(a) as being unpatentable over LEE ET AL. (Journal of Pharmaceutical Sciences, 1980, vol. 69, no. 9, p.1050-1056) and WO 01/58888 A1 (Published August 16, 2001).
Regarding claims 1-6 and 18, LEE ET AL. teach compounds I and Ia:
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(p.1050, right column). Compound Ia is a compound of the claimed formula I wherein R1 is -C(O)C1-6 alkyl (-CH3) and R2 is -C(O)C(=CH2)CH3. Lee et al. teach that compound I, i.e., molephantin, has antitumor activity against Ehrlich Ascites carcinoma, Walker 256 Carcinoma, and P-388 lymphocytic leukemia (Table I).
Regarding claims 1-6 and 18, WO ‘888 teaches compound 13:
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(p.15, Compound 13; Example 11; Claim 6). Compound 13 is a compound of the claimed formula I wherein R1 is -C(O)C1-6 alkyl (-CH3) and R2 is -C(O)C(=CH2)CH3 and is the same compound as compound Ia taught in Lee et al. WO ‘888 also teaches Compound 1, i.e., molephantin, as a compound of its invention having antiprotozoal activity:
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(p.5-6). This is the same Compound I taught in Lee et al. to have antitumor activity. Regarding claim 10, WO ‘888 teaches pharmaceutical composition comprising a compound taught therein and a pharmaceutically acceptable adjuvant, diluent, or carrier (p.16; p.26-27, p.42-43).
Claim 14-16 differ from the combined teachings of Lee et al. and WO ‘888 in so far as Compound Ia (Lee et al.)/Compound 13 (WO ‘888) is not expressly disclosed to have anticancer activity.
It would have been obvious to a person of ordinary skill in the art to administer the molephantin derivative Compound Ia (Lee et al.)/Compound 13 (WO ‘888) to treat cancer. The compound is structurally similar to the natural product molephantin (Compound I taught in both Lee et al. and WO ‘888), differing only in the replacement of a single hydrogen with a -C(O)CH3 group. The skilled artisan would reasonably expect this compound to have similar biological activity as molephantin as evidenced by WO ‘888, who demonstrate that both molephantin and Compound Ia (Lee et al.)/Compound 13 (WO ‘888) have antiprotozoal activity (Table 1). Given the fact that molephantin was known to have anticancer/antitumor against three different cancer cell lines in vivo, there would have been reasonable expectation in the art that Compound Ia (Lee et al.)/Compound 13 (WO ‘888) would also have anticancer/antitumor activity.
Allowable Subject Matter
Claims 7-9 and 17 are 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
Claims 1-6, 10, 14-16, and 18 are rejected.
Claims 7-9 and 17 are objected to.
Applicant is requested to specifically point out the support for any amendments made to the disclosure in response to this Office action, including the claims (M.P.E.P. §§ 714.02 and 2163.06). In doing so, applicant is requested to refer to pages and line (or paragraph) numbers (if available) in the as-filed specification, not the published application. Due to the procedure outlined in M.P.E.P. § 2163.06 for interpreting claims, other art may be applicable under 35 U.S.C. § 102 or 35 U.S.C. § 103(a) once the aforementioned issue(s) is/are addressed.
Applicant is reminded that MPEP §2001.06(b) clearly states that “[t]he individuals covered by 37 C.F.R. 1.56 have a duty to bring to the attention of the examiner, or other Office official involved with the examination of a particular application, information within their knowledge as to other copending United States applications which are "material to patentability" of the application in question." See Armour & Co. v. Swift & Co., 466 F.2d 767, 779, 175 USPQ 70, 79 (7th Cir. 1972). MPEP §2001.06(b) clearly indicates that “if a particular inventor has different applications pending in which similar subject matter but patentably indistinct claims are present that fact must be disclosed to the examiner of each of the involved applications.” See Dayco Prod. Inc. v. Total Containment, Inc., 329 F.3d 1358, 1365-69, 66 USPQ2d 1801, 1806-08 (Fed. Cir. 2003).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES D ANDERSON whose telephone number is (571)272-9038. The examiner can normally be reached on Monday-Friday, 7:30 am - 4:00 pm PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/James D. Anderson/Primary Examiner, Art Unit 1629
UNITED STATES PATENT AND TRADEMARK OFFICE
500 Dulany Street
Alexandria, VA 22314-5774
Tel. No.: (571) 272-9038
1 Applicants define the term “alkyl” to refer to an unbranched or branched, acyclic or cyclic, saturated or unsaturated (so forming, for example, an alkenyl or alkynyl) hydrocarbon radical (Specification at p.22, l.14-16). As such, the moiety -C(O)C(=CH2)CH3 is also a -C(O)C1-6 alkyl as defined in claim 1.
2 Applicants define the term “alkyl” to refer to an unbranched or branched, acyclic or cyclic, saturated or unsaturated (so forming, for example, an alkenyl or alkynyl) hydrocarbon radical (Specification at p.22, l.14-16). As such, the moiety -C(O)C(=CH2)CH3 is also a -C(O)C1-6 alkyl as defined in claim 1.