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’ filling of the claims on 11/30/2023. Claims 1-20 are pending and are examined based on the merits herein.
Application Priority
This application filed 11/30/2023 claims foreign priority to 112142118, filed 11/01/2023.
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) 1-9 are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. (US 20130171276), Giudetti (Frontiers in Physiology, 31 August 2023), Marinetti (Disorders of Lipid Metabolism, 1990) and Li (CN 102516193).
Kim et al. disclose tablet pharmaceutical composition comprising Cudrania tricuspidata extract and Coix lachryma-jobi extract, for suppressing obesity (Abstract, claim 1). The anti-obesity effect is measured with Cudrania tricuspidata and Coix lachryma-jobi Extracts indicating its effects on lipid accumulation (Example 3).
Giudetti is explicit in teaching that obesity is associated with lipid metabolism or lipid metabolism alterations (see title, p 1, lines 7-8). Also taught is that lipid accumulation in the liver is non-alcoholic fatty liver disease (NAFLD) and represents the initial form of metabolic impairment (p 1, lines 14-16).
Marinetti is explicit in teaching that common lipid disorders include obesity. Obesity, the accumulation of excess fat in adipose tissue (p 1, last para to page 2, para 1, obesity).
Li et al. teach extraction of Coixol, an alkaloid compound, (CAS number 532-91-2) from Coix lacryma-jobi. In other words, Coix lachryma-jobi extract comprises the compound, 6-methoxybenzoxazolinone.
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A person skilled in the art from the above prior art teachings before the effective filing date of the invention would have found it obvious and arrived at the claimed method because (i) Kim et al. disclose pharmaceutical composition comprising Cudrania tricuspidata extract and Coix lachryma-jobi extract, for suppressing obesity (ii) Giudetti and Marinetti teach that lipid metabolism is associated with obesity (iii) Li is explicit in teaching that Coix lachryma-jobi extract comprises the compound, 6-methoxybenzoxazolinone (6-MBOA). A person skilled in the art would have been motivated to arrive at the method of modulation of lipid metabolism by administering to subjects with obesity, the extract that comprises 6-MBOA with a reasonable expectation of success. It is noted that administration of the same agent, 6-MBOA to subjects with obesity will result in the modulation of lipid metabolism as obesity is associated with it. Thus claim 1 would have been obvious over the prior art teachings. As to claims 2-6, the limitations are to the properties of 6-MBOA and as to claim 7, it is the mechanism of lipid metabolism modulation and hence administration of 6-MBOA results in the effects as claimed. As to claims 8-9, Kim teach tablet pharmaceutical composition comprising Coix lachryma-jobi extract thus addressing the claims.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Sun (CN 107349358 A), Nie (CN 111184842 A), Shin et al. (KR 20050078868) and Li (CN 102516193).
Sun teaches a capsule medication comprising coix seed (150-500 g) for treating non-alcoholic fatty liver disease (NAFLD) (Abstract, claim 1, Examples 1-3).
Nie teach traditional Chinese medicine composition, comprising 1-5 parts of fried coix seed for treating fatty liver disease (NAFLD) (See claims 1, 5, 6). Further taught is that metabolic syndrome includes obesity (see p 3, lines 5-6).
Shin et al. disclose composition comprising Coix lachoryma-jobi (5-50 parts) for the treatment of obesity (Abstract, claim 1). The formulation is in the form of liquid, tablet, capsule, syrup or injection (claim 4).
Li et al. teach extraction of Coixol, an alkaloid compound, (CAS number 532-91-2) from Coix lacryma-jobi. In other words, Coix lachryma-jobi extract comprises the compound, 6-methoxybenzoxazolinone.
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The reference teach uses membrane filtration technology for purification of coix seed [0009] and further teach the extraction technique of Coix (See [0011-12]).
A person skilled in the art from the above prior art teachings before the effective filing date of the invention would have found it obvious to arrive at the method of treating obesity, improving NAFLD and metabolic syndrome because (i) Sun disclose pharmaceutical composition, capsule comprising Coix seed for NAFLD (ii) Li is explicit in teaching that Coix lachryma-jobi extract is obtained from coix seed and the extract comprises the compound, 6-methoxybenzoxazolinone (6-MBOA) and (iii) Nie teach metabolic syndrome includes obesity (iv) Shin teach treating obesity with Coix lachryma-jobi extract. A person skilled in the art would have been motivated to arrive at the method of modulation of lipid metabolism by administering to subjects with obesity, the extract that comprises 6-MBOA with a reasonable expectation of success. It is noted that administration of the same agent, 6-MBOA to subjects with obesity will result in the modulation of lipid metabolism as obesity is associated with it. Thus claim 1 would have been obvious over the prior art teachings. As to claims 2-6, the limitations are to the properties of 6-MBOA and as to claim 7, it is the mechanism of lipid metabolism modulation and hence administration of 6-MBOA results in the effects as claimed. As to claims 8-9, Shin teach tablet pharmaceutical composition comprising Coix lachryma-jobi extract thus addressing the claims. A person skilled in the art would have been motivated to arrive at improving NAFLD and metabolic syndrome with a reasonable expectation of success by administration of coix seed and/or Coix lachryma-jobi extract that comprises 6-MBOA. Thus claim 10 would have been obvious over the prior art teachings. As to claims 11-16, the administration coix seed that comprises 6-MBOA results in the pharmacological effects as claimed. As to claim 17, 19, Sun teach capsule pharmaceutical composition that comprises coix seed that comprises 6-MBOA thus addressing the claims. As to claims 18 and 20, a person skilled in the art from Shin’s teaching would have found it obvious to administer the pharmaceutical composition that comprises 6-MBOA for parenteral administration (e.g. injection) and the dosage form as solution.
Note: The prior art made of record and not relied upon is considered pertinent toapplicant's disclosure: JP 2002275078 teach lipolysis promoter comprising an extract essence from Coix lachryma- Jobi. Yang et al. (CN 103330865 A) teach medicinal composition comprising coix see (3-10 parts) in treating non-alcoholic steatohepatitis (abstract, claim 1, [0007]), the pharmaceutical formulation a honeyed pill (claim 3).
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of co-pending Application No. 18/220475 (reference application, ‘475) in view of Zhou et al. (CN 115944700) and further in view of and Li (CN 102516193).
The instantly claimed methods are directed to:
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The reference claims are directed to:
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The reference claims are not explicit in teaching modulation of lipid metabolism or NAFLD or metabolic syndrome as instantly claimed.
Zhou teach obesity, NAFLD, liver fibrosis, metabolism syndrome are all related excessive lipid accumulation diseases and are treated with a pharmaceutical composition comprising 15 parts of coix seed (See claims 1-3, 9-10).
Zhou is not explicit in teaching that coix seed comprises 6-MBOA.
Li et al. teach extraction of Coixol, an alkaloid compound, (CAS number 532-91-2) from Coix lacryma-jobi. In other words, Coix lachryma-jobi extract comprises the compound, 6-methoxybenzoxazolinone.
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The reference teach uses membrane filtration technology for purification of coix seed [0009] and further teach the extraction technique of Coix (See [0011-12]).
A person skilled in the art would have found it obvious from the reference claims, Zhou and Li et al. to arrive at the claimed methods because (i) the reference claims teach the use of 6-MBOA or Coix lacryma-jobi extract comprising 6-MBOA for liver fibrosis treatment (ii) Zhou teach treating lipid accumulation and its related diseases, liver fibrosis, obesity, NAFLD, metabolic syndrome in subjects with composition comprising Coix seed (iii) Li teach that coix seed Coix lachryma-jobi extract source comprises the compound, 6-methoxybenzoxazolinone. From such teachings a skilled artisan would have found it obvious to treat lipid accumulation and its related diseases, obesity, NAFLD, metabolic syndrome in subjects with 6-MBOA or the extract comprising 6-MBOA with a reasonable expectation of success thus addressing claims 1, 10. As to claims 2-6, 11-15, the limitations are to the properties of 6-MBOA and as to claim 7, it is the mechanism of lipid metabolism modulation. Hence administration of 6-MBOA or the extract comprising 6-MBOA would result in the pharmacological effects as claimed. As to claims 16-20, the dosage forms oral, parenteral, the pharmaceutical composition comprising excipient and the dosage form being powder, solution etc. are addressed by the reference claims 16-20.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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
Prosecution Insights