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 .
Priority
This application is a 371 of PCT/KR2023/003227 (03/09/2023)
and claims foreign priority to KOREA, REPUBLIC OF 10-2022-0069114 (06/07/2022).
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.
Claims 1-6, 8-9, 13-18 are rejected under 35 U.S.C. 112(b) 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.
The claim includes “R” variables, however, the claim uses subscript numbers associated with the “R” groups while also using C1 such as follows:
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.
One of skill in the art would find the mixed notation confusing both because the accepted use in the art is superscript (to avoid confusion with a repeating group like CH3) to indicate a R label, while subscript is appropriate for repeating units. Thus the claims are rejected as indefinite.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang et al. (Biomedicine & Pharmacotherapy 121 (2020) 109599, 7 pages).
Huang teaches treating complications of diabetes including diabetic nephropathy (DN) with tripterygium extracts compositions comprising demethylzeylasteral (p. 1-2, Fig 1):
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Demethylzeylasteral corresponds to claim 1’s formula 1 when R1 is OH, R2 is OH, R3 is CHO, and R4 is COOH. Huang teaches administration of the composition to humans in clinical trials (Table 1). Thus, Huang anticipates the claims.
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.
Claims 1-6, 8-9, 13-18 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (Biomedicine & Pharmacotherapy 121 (2020) 109599, 7 pages).
Huang teaches as in the 35 USC 102 rejection above and also renders claims 1-5 obvious.
Regarding claim 6, Huang does not specifically teach reducing body fat.
However, Huang teaches “tripterygium and its extracts are widely used in the treatment of chronic autoimmune/inflammatory diseases”, “Moreover, celastrol (an important extract of tripterygium) could be a leptin sensitizer and a promising agent for treating obesity” (p. 2).
One of ordinary skill in the art would have considered Huang’s teaching of the use of the same extracts in treating obesity because Huang specifically teaches a component of the extract was shown to be a promising treatment for obesity and the compound share substantial structural similarity among demethylzeylasteral and celestrol (Fig. 1) and the two compounds are present in the same extract.
Regarding claim 13, to a food composition, the instant specification describes a tablet as a food.
Regarding claim 14 to a method for modulating blood pressure and blood glucose by administering the same compound, Huang does not specifically teach these conditions. However, one of ordinary skill in the art treating a diabetic patient as per Huang with the same composition would inherently also treat these same conditions and arrive at the claimed invention.
With each of the claims, the level of skill in the art is very high such that one of ordinary skill in the art would consider routine the combination of elements from the teaching of the art. One of ordinary skill in the art would have recognized that the results of the combination would be predictable due to the well-known nature and optimizations routinely performed in the art. Thus, one of ordinary skill in the art would have arrived at the invention as claimed before the effective filing date with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8-9, 13-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 12-15 of copending Application No. 18877431 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application claims a method of treating disease comprising administering the same compound in the same manner as in the instant claims and particularly when construed in view of the specification ([0076]) which anticipates and renders obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT H HAVLIN whose telephone number is (571)272-9066. The examiner can normally be reached 9am - 6pm.
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/ROBERT H HAVLIN/Primary Patent Examiner, Art Unit 1626
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