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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/5/2024 was considered by the examiner.
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.
Claims 11-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alvarado et al. (Biomed Res Int, 2016, 1-10; of record) in view of Lee et al. (Acta Orthopedica et Trauma, 52, 2018, 58-64).
Alvarado is directed to using maqui berry extract, Delphinol®, to inhibit glucose absorption. Alvarado teaches that Delphinol® (the maqui extract) contains 25% w/w delphinidin glycosides (i.e. ‘delphinidins’ as recited by instant claim 11) and 35% total anthocyanins (see instant claim 11) (see page 2). The composition is administered to subjects in the form of a capsule (see page 2, section 2.2) (see instant claims 22 and 23).
Claims 11-20 recite product-by-process limitations for how the maqui berry extract used in the method of claim 11 is obtained (“obtained by the following steps: a) providing a crude extract of a plant material…”, wherein said adsorbent of steps c.) and d.) is a resin, etc). However, the process by which the product of the method is made is not limited to the manipulations of the recited steps but instead the structure/composition implied thereby. See MPEP 2113(I). In the instant case, the methods composition comprises 25% w/w delphinidin and 35% total anthocyanins which is overlapping with the extract described by Alvarado and so even if the prior art describes a different process of making the extract it is considered immaterial because the final product has the same structure/composition.
Alvarado fails to teach the method as treating a bone disease or defect selected from the group of congenital bone defects, bone or spinal deformation, osteosarcoma, bone dysplasia, osteomalacia (rickets), osteogenesis imperfecta (brittle bone disorder) or Paget's disease.
Lee is directed understanding the role delphinidins play in treating osteosarcoma. It is taught that delphinidins compromise the cellular protective mechanisms by inhibiting autophagy thereby allowing reactive oxygen species to accumulate and enhance apoptotic cell death in osteosarcoma (see abstract, Figure B6 and page 63). Thus, it would have been obvious to modify Alvarado’s method of administering delphinidins such that it was used in methods of treating osteosarcoma, as taught by Lee. See MPEP 2143(I)(C) which states applying a known technique (using delphinidins to treat osteosarcoma) to a known method (administering delphinidins to treat blood glucose) ready for improvement to yield predictable results is supportive of obviousness.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
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 11-23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-14 of US 12551520 in view of Lee et al. (Acta Orthopedica et Trauma, 52, 2018, 58-64).
US 12551520 is directed to a method of treating an inflamed skin condition comprising administering to a subject in need thereof a medicament or dietary supplement comprising maqui berry extract, wherein the maqui berry extract comprises a minimum of 25% (w/w) delphinidins and a minimum of 35% (w/w) anthocyanins, and wherein the extract is obtained by the following steps: a) providing a crude extract of a plant material, b) filtering said crude extract; c) contacting said crude extract with an adsorbent, wherein said adsorbent, in particular resin adsorbs said anthocyanins; d) washing said adsorbent; and e) eluting said anthocyanins from said adsorbent to obtain a composition enriched for anthocyanins. The reference fails to teach the method as being used in a method of treating a bone disease or defect selected from the group of congenital bone defects, bone or spinal deformation, osteosarcoma, bone dysplasia, osteomalacia (rickets), osteogenesis imperfecta (brittle bone disorder) or Paget's disease. Lee remedies this shortcoming. Lee teaches that delphinidins compromise the cellular protective mechanisms by inhibiting autophagy thereby allowing reactive oxygen species to accumulate and enhance apoptotic cell death in osteosarcoma (see abstract, Figure B6 and page 63). Thus, it would have been obvious to modify the patents method of administering delphinidins such that it was used in methods of treating osteosarcoma, as taught by Lee, with a reasonable expectation for success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Bethany Barham, can be reached on 571-272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611
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