DETAILED ACTION
1. The present application is being examined under the pre-AIA first to invent provisions.
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 15, 2025 has been entered.
3. Claims 1 and 6 are currently pending.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
4. Claims 1 and 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Moraru (RO 119924 B1 English translation) and Pak (US 4,772,467).
Moraru teaches a method for treating osteoporosis by administering a composition comprising 24% drone brood (drone larvae). The reference teaches that the ingredients are powdered and encapsulated. The reference teaches administering calcium to treat osteoporosis (see pages 3 and 4 of the translation) but does not specifically teach administering the calcium in combination with the drone brood or in a preparation such as calcium citrate.
Pak teaches a method for treating osteoporosis by administering calcium citrate (see abstract and claims).
These references show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions that treat osteoporosis. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art.
Based on the disclosure by these references that these substances are used in compositions to treat osteoporosis, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to treat osteoporosis. Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See MPEP section 2144.06, In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980), Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992).
The references do not specifically teach combining the ingredients in the percentages claimed by applicant. However, the amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The references teach that each of the claimed ingredients is a pharmaceutically active ingredient. An artisan of ordinary skill would routinely modify the amount of pharmaceutically active ingredients based on the patient's age, weight, gender, and condition. Therefore, an artisan would have been motivated to modify the amount of each ingredient in the combination in order to formulate a product that best achieves the desired results set forth in the reference. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of applicant’s invention.
The references do not teach that the compounds have all of the same effects as claimed by applicant in claim 1. However, the fact that applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Response to Arguments
Applicant's arguments filed September 15, 2025 have been fully considered but they are not persuasive. Applicant argues that the citation of Moraru is improper hindsight because this reference was submitted to the Office in the parent application. However, as discussed in the previous Office action, even if the applicant files a reference in an Information Disclosure Statement, this does not disqualify the reference as prior art. The MPEP specifically states that the first step in searching an application is to review art cited by applicant in the current case and in any parent cases (see MPEP section 904.02(b)). Thus, the use of references cited by applicant is not improper; in fact, it would be considered erroneous to ignore a pertinent reference simply because applicant cited it in a parent case. Therefore, applicant’s argument is not persuasive.
Double Patenting
5. Claims 1 and 6 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 9,827,273 in view of Pak (US 4,772,467) for the reasons set forth in the previous Office action.
6. Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 8 of copending Application No. 15/230,746 for the reasons set forth in the previous Office action.
7. Claims 1 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 5 and 6 of copending Application No. 15/796,734 (reference applications) in view of Pak (US 4,772,467) for the reasons set forth in the previous Office action.
Applicant has requested that the double patenting rejections be held in abeyance until allowable subject matter is indicated. The request is noted. The rejections are currently still considered valid at this time for the reasons set forth in the previous Office action.
8. No claims are allowed.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Susan Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655
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