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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 28, 2025 has been entered.
3. Claims 5 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 5 and 6 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lazarjan (RU 2287334 C2 – English translation) in view of Paul (US Pat. No. 5,292,538).
Lazarjan teaches a composition comprising a drone brood homogenate which is useful for promoting anabolism. The composition can be in the form of a tablet. The reference teaching using a dosage of 10 mg/kg – 20 mg/kg (see paragraphs 6, 15, and 16).
Paul teaches a composition for promoting anabolism comprising 50 to 200 IU of vitamin D (see claims 13 and 19).
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 promote anabolism. 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 promote anabolism, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating compositions to promote anabolism. 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 administering the ingredients in all of the amounts claimed by applicant. However, the dosage of a pharmaceutical ingredient 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 dosage 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 dosage amount would have been obvious at the time of applicant’s invention.
The references do not teach that the composition has the same effects on the body as claimed by applicant. However, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The references together teach combining the same ingredients together into a single composition. Thus, the composition taught by reference should be capable of performing the claimed intended uses if applicant’s invention functions as claimed.
Response to Arguments
Applicant's arguments filed October 14, 2024 have been fully considered but they are not persuasive. Applicant argues:
It was pointed out in the response of October 14, 2024, that claimed was a preparation for preventing and treating atypical osteoporosis with normal or increased bone tissue mineralization with the presence of cavities in trabecular bone sections.
This must be the only thing known by default to an ordinary person skilled in the art (OPSA) and presenting the concern thereto to direct a search by the OPSA.
Obliged to be guided by that concern, the OPSA searched and found the Lazaryan’s substances comprising drone brood and demonstrating anabolic and actoprotecting actions.
As it seems, the preparation for preventing and treating atypical osteoporosis and the substance of anabolic and actoprotecting action have nothing in common on the assumption that the search was based on the above point of concern, the only criteria by which the OPSA must be guided in the search.
The inexplicability of OPSA who found Lazaryan becomes understandable upon comparing components used and claimed by the applicant on the one hand and disclosed by Lazaryan on the other.
However, the components used and claimed by the applicant are what the OPSA cannot know by default. They can only appear from knowledge gleaned from the applicant’s disclosure (See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971)). And this is impermissible.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
MPEP section 2141.01(a) clearly states that references are considered to in the same field of endeavor even if they are concerned with a different problem. This is directly applicable to the facts in the case where the rejection is based on references concerned with anabolism vs. atypical osteoporosis. The reasoning used to reject applicant’s claims under 103 is clearly set forth in the MPEP as discussed above and in the previous Office actions. All of applicant’s arguments address matters that have been discussed in the case law cited in the MPEP and cited above. The MPEP is clear on these points. Thus, applicant’s arguments are not persuasive.
Double Patenting
5. Claims 5 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 for the reasons set forth in the previous Office action.
Applicant has requested that this rejection be held in abeyance until allowable subject matter is indicated. The request is noted. The rejection is currently still considered valid at this time for the reasons set forth in the previous Office action.
6. Claims 5 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 16/706,639 (reference application) for the reasons set forth in the previous Office action.
Applicant has requested that this rejection be held in abeyance until allowable subject matter is indicated. The request is noted. The rejection is currently still considered valid at this time for the reasons set forth in the previous Office action.
7. Claims 5 and 6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 3 of copending Application No. 14/395,482 (reference application) for the reasons set forth in the previous Office action.
Applicant has requested that this rejection be held in abeyance until allowable subject matter is indicated. The request is noted. The rejection is 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 Coe Hoffman whose telephone number is (571)272-0963. The examiner can normally be reached M-Th 8:30am - 3:30pm.
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/SUSAN HOFFMAN/ Primary Examiner, Art Unit 1655