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 .
Response to Arguments
Applicant’s response from 10/2/2025 is acknowledged.
Claim Objections
In view of Applicant’s claim amendments, the objections are hereby withdrawn.
The Examiner does not note for the record, however, that Applicant made amendments to the claim, but the instantly filed claim set does not properly reflect that such amendments were made. Specifically, the previous office action provided. “Claim 1 recites the limitation “treatment or prevention of a calcium deficiency–/–depletion disorder”. The dashes in “–/–“ appear to be redundant and improper punctuation. Appropriate correction is requested.” The instant claim set from 12/30/2025 does not reflect that Applicant amended the claim to remove “–/–“ from it.
Claim Rejections - 35 USC § 112(b)
In view of Applicant’s claim amendments, this rejection is hereby withdrawn.
Claim Rejections - 35 USC § 102- Liu as further evidenced by Decker
Claim Rejections - 35 USC § 103- Liu in view of Liu 2
Claim Rejections - 35 USC § 102- Horcajada as further evidenced by Chaney
Applicant has amended the claims to remove the previously elected species, and has now presented claims to a previously unelected/ unexamined species. In view of Applicant’s claim amendments, these rejections are hereby withdrawn.
In view of Applicant’s claim amendments, a new rejection has been made below over another patent application in the Horcajada family tree.
Double patenting
In view of Applicant’s claim amendments the rejections over the issued patents are hereby withdrawn. The provisional rejection over patent application 17/595,159 ongoingly has overlapping subject matter, and is hereby amended and maintained.
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.
(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, 4, 6-8 and 21-25 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by US 20160045519 A1 to Horcajada et al. (“Horcajada 2”).
Horcajada 2 relates to use of a composition for maintenance of bone and/or cartilage health or prevention, alleviation and/or treatment of bone and/or cartilage disorders. (Abstract). Per Horcajada 2, a composition for use according to the invention relates to use in treatment of disorders in bone formation and/or cartilage anabolism such as hypocalcemia due to a cancer, multiple myelomas, periodontal diseases, osteoarthritis, bone deficit resulting from a fracture or fracture healing. ([0086]). Hypocalcemia is a term of art, which indicates calcium deficiency/ depletion disorder.
Claim 1 is directed to a method for potentiating the effects of one or more polyphenols on bone formation and/or cartilage anabolism comprising administering a composition comprising Vitamin D to an individual in need of same. Claim 2 recites wherein the polyphenols are one or more of oleuropein and hydroxytyrosol. Claims 7 and 8 recite wherein the composition further comprises one or more bioactive molecules, i.e. mineral calcium. Claim 15 recites that the composition is a nutritional composition. Per Horcajada 2, the nutritional composition of one or more of oleoeuropein and Hydroxytyrosol is suitable for a daily oral administration included from 0.01 mg to 500 mg of each component. ([0070]). It can further comprise one or more of (whey) protein, carbohydrate, fat. ([0066-68]). The quantity of calcium contained in a nutritional composition according to the invention is adapted for a daily administration, provided by the said composition, included between 100 mg and 1000 mg, preferably between 200 mg and 700 mg and very preferably between 300 mg and 600 mg of calcium. ([0071]). A composition of the invention is administered at least once a day for a time period of at least 1 month, such as at least 2 months, preferably at least 3 months. ([0119]). Horcajada discloses that a source of the oleuropeain can be the olive tree ([0010], [0044]), which discloses an extract from the Oleaceae family (see, e.g., Applicant’s specification at [0073]).
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, 4 and 6-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6-8, 21-25 of copending Application No. 17/595,159 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter.
The claims of the instant application, with reference to Applicant’s amended claim 1, are directed to a method of achieving at least one result selected from (i) improvement in muscle fatigue or weakness, and (ii) treatment or prevention of a calcium deficiency/depletion disorder in an individual in need thereof, the method comprising orally administering to the individual a composition comprising an effective amount of a compound selected from the group consisting of oleuropein, homovanillyl alcohol, isohomovanillyl alcohol, and combinations thereof.
The claims of the co-pending application are directed in relevant part to: a method of achieving at least one result selected from the group consisting of . . . (vii) treatment of a muscle disorder linked to calcium depletion or deficiency, the method comprising orally administering to an individual an effective amount of a combination of calcium and at least one of oleuropein or metabolite thereof, wherein the metabolite of oleuropein is selected from the group consisting of oleuropein aglycone, hydroxytyrosol, homovanillyl alcohol, isohomovanillyl alcohol and mixtures thereof (claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SVETLANA M IVANOVA whose telephone number is (571)270-3277. The examiner can normally be reached 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L. Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SVETLANA M IVANOVA/Primary Examiner, Art Unit 1627