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
The office acknowledges Applicants filing of the claim amendments on 7/12/2024. Claims 1-8 have been amended. Claims 1-10 are pending and are examined based on the merits herein.
Application Priority
This application filed on 7/12/2024 is a National Stage entry of PCT/CN2023/ 131184, International Filing Date: 11/13/2023, claims foreign priority to 202211460109.4, filed 11/21/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 7/12/20-24 and 7/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
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.
Claim(s) 1, 2, 6-7, 10 are rejected under 35 U.S.C. 102(A)(1) as being by Zeng et al. (IDS: CN 110801449, 2/18/2020 publication date, also English translation attached).
Zeng discloses the preparation of methylenedioxy derivative for treating tumor (Abstract, [0012), claims 1-3, 10). It is further taught that the benzisoxazole selenozole derivatives are useful for inhibiting tumor cells in vitro or in vivo (See p 3, para 4, English translation).
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Zeng disclose pharmaceutical composition comprising the medicine and a pharmaceutically acceptable excipient, for oral preparation, e.g. tablet, injection administration, e.g. powder (See p 4, last three paragraph, lines 11-13 of p 5). The dosage amount 1-500 mg/kg, the concentration is 1-100uM is taught (see p 5, para 1-2 of English translation, claim 9).
Note: Claim 1 has been interpreted as a method for preparation of the drug. The drug is defined as ‘a substance used as a medication or in the preparation of medication’. As to the limitation of ‘treatment of spinaglioma’ it is to intended use of the drug prepared. Applicants are reminded that claim language which merely recites a purpose or intended use of a claimed invention that is otherwise fully and intrinsically set forth by the remainder of the claim, such language is of no consequence to the construction of the invention claimed. MPEP 2111.02(II). Statements of intended use do not serve to distinguish structure over the prior art. See In re Pearson, 494 F .2d 1399, 1403, 181 USPQ 641, 644 (CCPA 1974); In re Yanush, 477, F .2d 958, 959, 177 USPQ 705, 706 (CCPA 1973); In re Casey, 370 F .2d 576, 580, 152 USPQ 235, 238 (CCPA 1967). It is noted that the claim does not require additional steps to be performed and simply expresses the intended result of carrying the process". The claim does not require administration of the drug or the subject(s) to be administered/treated.
Zeng anticipates the preparation of the drug composition of benzoisoselenazole derivative compound of instant claim 1 thus addressing claims 1 and 7. As to claim 2, the limitations are to specific grade spinaglioma. As stated above, the claims are to the drug preparation and not to the treatment or intended use. Hence the claim is anticipated as Zeng teaches drug preparation of formula I. As to the dosage form injection or oral dosage form of the drug is taught by Zeng thus anticipating claims 6, 10.
Claim(s) 1, 2, 6-8, 10 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Zeng et al. (CN 110856718 A, 3/3/2020 publication date, also English translation attached).
Zeng discloses application of benzoisoselenazole derivatives and platinum medicine in preparing medicine for treating tumor and inhibiting postoperative tumor recurrence (abstract, claims 1-3, 5). The benzoisoselenazole derivative taught has the following structure:
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The reference also provides a pharmaceutical composition, said pharmaceutical composition comprising alkoxy derivatives and platinum anticancer drug; the pharmaceutical composition comprising diluent, binder, antioxidant etc. (), the dosage form as tablet, capsule for oral administration, powder for injection (p 5, para 5, 8, English translation). Zeng disclose the alkoxy derivative agent is administered in an amount of 10-600 mg/kg (p 6, para 6) and benzoisoselenazole, a stock solution of 10 mM and working solution with a desired concentration of 15, 20, 20 and 40 uM (p 14, 1.5, liquid medicine preparation, English translation).
It is noted that claim 1 has been interpreted as a method for preparation of the drug (See above). Zeng anticipates the preparation of the drug composition of benzoisoselenazole derivative compound of instant claim 1 thus addressing claims 1 and 7. As to claim 2, the limitations are to specific grade spinaglioma. As stated above, the claims are to the drug preparation and not to the treatment or intended use. Hence the claim is anticipated as Zeng teaches preparation of formula I. As to the dosage form injection or oral dosage form of the drug is taught by Zeng thus anticipating claims 6, 10. Claim 8 is anticipated by Zeng because the reference teaches 15 uM solution of benzoisoselenazole for experiments, which equates to 6.75 mg/ml and this falls within the claimed range of 0.2-7.92 mg/ml.
Claim(s) 1, 2, 6-7, 10 are rejected under 35 U.S.C. 102(A)(1) as being by Zeng et al. (IDS: CN 1990475 B, 9/7/2011 publication date, also English translation attached).
Zeng disclose substituted benzo-iso-selenium ketone derivative, and a substituted benzo selenium ketone derivative and its use for preparing a pharmaceutical composition for treating inflammation, tumor or thrombosis of drug (Abstract).
Zeng discloses the following compounds which includes the compound of formula I of the instant claim when R2 is 4.
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Further Zeng teaches its pharmaceutical composition with an excipient or carrier [0067], such as cyclodextrin (alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin), the normal injection agent include Tween-80 [0070], the dosage forms suitable for oral, injection [0068] (English translation), the compound can be administered at a dose of 0.05-250 mg/kg [0083] (See claims).
It is noted that claim 1 has been interpreted as a method for preparation of the drug (See above). Zeng anticipates the preparation of the drug composition of benzoisoselenazole derivative compound of instant claim 1 thus addressing claims 1 and 7. As to claim 2, the limitations are to specific grade spinaglioma. As stated above, the claims are to the drug preparation and not to the treatment or intended use. Hence the claim is anticipated as Zeng teaches preparation of formula I. As to the dosage form injection or oral dosage form of the drug is taught by Zeng thus anticipating claims 6, 10.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-7, 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (IDS: CN 1990475 B, 9/7/2011 publication date, also English translation attached).
Zeng disclose substituted benzo-iso-selenium ketone derivative, and a substituted benzo selenium ketone derivative and its use for preparing a pharmaceutical composition for treating inflammation, tumor or thrombosis of drug, brain stem glioma etc. (Abstract, [0074]). Zeng discloses the following compounds which includes the compound of formula I of the instant claim when R2 is 4.
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Further Zeng teaches its pharmaceutical composition with an excipient or carrier [0067], such as cyclodextrin (alpha-cyclodextrin, beta-cyclodextrin, gamma-cyclodextrin), the normal injection agent include Tween-80 [0070], the dosage forms suitable for oral, injection [0068] (English translation), the compound can be administered at a dose of 0.05-250 mg/kg [0083] (See claims). The reference teaches the active agents are administered at a dose of 0.5-200 mg/kg body weight [0083] and with a concentration of 10 mg/ml solution [0215].
It is noted that claim 1 has been interpreted as a method for preparation of the drug (See above). Zeng teaches the preparation of the compound of formula I, its pharmaceutical composition, dosage forms for oral, and injection thus addressing claims 1, 6-7 and 10. As to claim 2, the limitations are to specific grade spinaglioma. As stated above, the claims are to the drug preparation and not to the treatment or intended use. As to claim 4, it would have been obvious from the reference that the drug prepared can be used for oral or injection administration with a reasonable expectation of success. As to claims 5 and 10 Zeng teach that the injection preparation excipient includes Tween-80. Hence a skilled artisan would have been motivated to add Tween-80 as an excipient in the drug composition with a reasonable expectation of success and for use in therapy.
Claim(s) 3, 8 are rejected under 35 U.S.C. 103 as being unpatentable over Zeng et al. (IDS: CN 1990475 B, 9/7/2011 publication date, also English translation attached) and Nair (J of Basic and Clinical Pharmacology, 7, 2, 2016, 27-31) .
Zeng teachings as above. The above rejection is incorporated herein.
Nair teach the human equivalent dose conversion of dose mg/kg to mg/m2 as 37 for 60 kg human (reference body weight) (See Table 1, Species, Human, line 1).
As to claims 3, 8 a skilled artisan would have found it obvious to prepare the drug of formula (I) in an amount for e.g. 18.5 mg/m2, if 0.5 mg/kg body weight is used for administration (0.5x37 (dose mg/kg to mg/m2 dose conversion factor)). As to the content, the reference teaches 10 mg/ml solution, it is within the skill of an artisan to dilute or adjust the concentrations as in the instant claim 3 as the dosage concentration optimization is routine. A skilled artisan would have been motivated to arrive at the drug dosage concentration with a reasonable expectation of success and to test the drug for its therapeutic effects.
Claim Rejections - 35 USC § 112
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 3-4 recites the limitation (i) in claim 3, ‘according to claim 1, wherein a dosage of the benzisoselenazole compound’ and (ii) in claim 4, "according to claim 1, wherein administration of the drug comprises’ in lines 1-2. There is insufficient antecedent basis for this limitation in the claim as there is no dosage or dosage amount or administering or administration steps in claim 1. It is noted that claim 1 as interpreted above is to preparation of the drug of compound of formula (I).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to UMAMAHESWARI RAMACHANDRAN whose telephone number is (571)272-9926. The examiner can normally be reached M-F- 8:30-5:00 PM (PST).
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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